GOHIBIC Dailymed
Generic: vilobelimab is used for the treatment of Covid-19
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FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR GOHIBIC HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use GOHIBIC under the EUA. See FULL FACT SHEET FOR HEALTHCARE PROVDERS for GOHIBIC.   ---------------------DOSAGE FORMS AND STRENGTHS--------------------- Injection: 200 mg/20 mL (10 mg/mL) in single-dose vials for further dilution. (3) GOHIBIC (vilobelimab) injection, for intravenous use Original EUA Authorized Date: 04/2023Revised EUA Authorized Date: 05/2023   -------------------------------CONTRAINDICATIONS----------------------------- No contraindications have been identified based on limited available data on emergency use of GOHIBIC authorized under this EUA. (4)   ------------------------RECENT MAJOR CHANGES----------------------- Emergency Use Authorization (1): revision to Information RegardingAvailable Alternatives for the EUA Authorized Use      05/2023 --------EMERGENCY USE AUTHORIZATION FOR GOHIBIC------- The U.S. Food and Drug Administration has issued an EUA for the emergency use of GOHIBIC for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). However, GOHIBIC is not FDA-approved for this use. (1) See Full Fact Sheet for Healthcare Providers for the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. ------------------------WARNINGS AND PRECAUTIONS----------------------- -------------------------------ADVERSE REACTIONS------------------------------ The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash. (6.1) ----------------------DOSAGE AND ADMINISTRATION------------------
- Recommended dosage of GOHIBIC is 800 mg administered by intravenous infusion after dilution, for a maximum of 6 (six) doses over the treatment period as described below. (2.1)
- Start treatment within 48 hours of intubation (Day 1), followed by administration of GOHIBIC on Days 2, 4, 8, 15 and 22 as long as the patient is still hospitalized (even if discharged from ICU). (2.1)
You or your designee must report all SERIOUS ADVERSE EVENTS or MEDICATION ERRORS potentially related to GOHIBIC by (1) submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to InflaRx GmbH at pvusa@inflarx.de (6.3) Preparation and Administration --------------------------USE IN SPECIFIC POPULATIONS---------------------
- Lactation: Discontinue drug or nursing taking into consideration importance of drug to mother. (8.2)
See PATIENT AND CAREGIVER FACT SHEET.
FULL PRESCRIBING INFORMATION: CONTENTS*
1 EMERGENCY USE AUTHORIZATION2 DOSAGE AND ADMINISTRATION
 2.1 Recommended Dosage 2.2 Preparation and Administration3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS
 5.1 Serious Infections 5.2 Hypersensitivity Reactions6 ADVERSE REACTIONS
 6.1 Clinical Trial Experience 6.3 Required Reporting for Serious Adverse Events and Medication Errors7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS
 8.1 Pregnancy 8.2 Lactation 8.3 Pediatric Use 8.4 Geriatric Use* Sections or subsections omitted from the EUA are not uled.
11 DESCRIPTION12 CLINICAL PHARMACOLOGY
 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 12.6 Immunogenicity13 NONCLINICAL TOXICOLOGY
 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION18 MANUFACTURER INFORMATION
FULL FACT SHEET FOR HEALTHCARE PROVIDERS
1 Emergency Use Authorization
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of GOHIBIC for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). However, GOHIBIC is not FDA-approved for this use.
Justification for Emergency Use of Drugs During the COVID-19 Pandemic
There is currently an outbreak of Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2, a novel coronavirus. The Secretary of HHS has:
- Determined that there is a public health emergency, or significant potential for a public health emergency, related to COVID-19
See U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020; https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. See also U.S. Department of Health and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b). March 15, 2023 ("Amended Determination"); https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration. .- Declared that circumstances exist justifying the authorization of emergency use of drugs and biological products for the prevention or treatment of COVID-19
See U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020); https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration. See also Amended Determination ("The declarations issued pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics, personal respiratory protective devices, other medical devices and drugs and biological products, as set forth in those declarations, and that are based on the February 4, 2020 determination, remain in effect until those declarations are terminated in accordance with section 564 of the FD&C Act."). .
An EUA is a FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances, including, but not limited to, when the Secretary of HHS declares that there is a public health emergency, or significant potential for a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:
- The biological agent(s) can cause a serious or life-threatening disease or condition;
- Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that:
- The product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and
- The known and potential benefits of the product – when used to diagnose, prevent or treat such disease or condition – outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s)
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.
Information Regarding Available Alternatives for the EUA Authorized UseThis section only describes the uses for which an FDA-approved drug is considered to be an alternative to GOHIBIC. For additional information, including the full indications for the FDA-approved drugs referenced within this section, please refer to the relevant Prescribing Information at: Drugs@FDA: FDA-Approved Drugs. As stated in the Letter of Authorization, the emergency use of GOHIBIC must be consistent with the terms and conditions of its authorization.
Veklury (remdesivir), a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, is an FDA-approved alternative to GOHIBIC when used for the treatment of COVID-19 in hospitalized adults and when initiated within 48 hours of receiving IMV, or ECMO. Veklury has demonstrated antiviral activity against SARS-CoV-2; whereas GOHIBIC acts by binding to C5a to block its interaction with the C5a receptor, both of which are components of the complement system thought to contribute to inflammation and worsening of COVID-19, offering a different mechanism of action.
Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, is an FDA-approved alternative to GOHIBIC when used for the treatment of COVID-19 in hospitalized adults and when initiated within 48 hours of requiring IMV, or ECMO. As noted, GOHIBIC offers a different mechanism of action. In addition, GOHIBIC has an intravenous route of administration; whereas, Olumiant is available as tablets, offering an alternative route of administration to adult patients who are mechanically ventilated or on ECMO.
Actemra (tocilizumab), an interleukin-6 (IL-6) receptor antagonist, is an FDA-approved alternative to GOHIBIC when used for the treatment of COVID-19 in hospitalized adults and when initiated within 48 hours of receiving IMV, or ECMO. As noted, GOHIBIC offers a different mechanism of action.
Other therapeutics are currently authorized for the same use as GOHIBIC. For additional information on all products authorized for the treatment of COVID-19, please see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
For information on clinical studies of GOHIBIC and other therapies for the treatment of COVID-19, see www.clinicaltrials.gov.
2 Dosage And Administration
2.1 Recommended Dosage
The recommended dosage of GOHIBIC for the treatment of adults with COVID-19 is 800 mg administered by intravenous infusion after dilution [see Dosage and Administration (2.2)] for a maximum of 6 (six) doses over the treatment period as described below.
Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU).
2.2 Preparation and Administration
Preparation
Using aseptic technique, dilute and prepare GOHIBIC for intravenous infusion before administration.
- For the recommended dose of 800 mg GOHIBIC, dilute 80 mL of GOHIBIC in 170 mL of 0.9% Sodium Chloride at room temperature.
- Use a 250 mL infusion bag of 0.9% Sodium Chloride solution USP and the follow steps below:
- Withdraw 80 mL of 0.9% Sodium Chloride solution USP from the infusion bag and discard.
- Withdraw the 80 mL of GOHIBIC from the vials and add slowly to the 0.9% Sodium Chloride solution USP infusion bag to a final concentration of 3.2 mg/mL.
- To mix the solution, gently invert the bag to avoid foaming.
Storage of Diluted GOHIBIC
- Diluted GOHIBIC must be used within 4 hours when stored at room temperature 20°C to 25°C (68°F to 77°F).
- Diluted GOHIBIC stored under refrigeration at 2°C to 8°C (36°F to 46°F) must be used within 24 hours.
- After removal of diluted GOHIBIC from the refrigerator stored at 2°C to 8°C (36°F to 46°F), it must be left to acclimatize to room temperature prior to administration.
Administration
- Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present.
- Administer diluted GOHIBIC via intravenous infusion over 30 - 60 minutes.
- Avoid concomitant administration of GOHIBIC with other drugs in the same intravenous line.
3 Dosage Forms And Strengths
Injection: 200 mg/20 mL (10 mg/mL) clear to slightly opalescent, colorless solution in a single-dose vial.
4 Contraindications
No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.
5 Warnings And Precautions
There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use.
5.1 Serious Infections
Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6)].
5.2 Hypersensitivity Reactions
Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.
6 Adverse Reactions
6.1 Clinical Trial Experience
The following adverse reactions have been observed in the clinical studies of GOHIBIC that supported the EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice.
The safety of GOHIBIC is based on PANAMO, a Phase 3 randomized, placebo-controlled trial in COVID-19 patients requiring IMV or ECMO [see Clinical Studies (14)]. The analysis of adverse reactions included a total of 364 adult patients who received at least one dose of either GOHIBIC (n=175) or placebo (n=189) plus standard of care. Patients received GOHIBIC 800 mg administered by intravenous infusion on Days 1, 2, 4, 8, 15 and 22 or placebo.
During the study, there were 62 deaths in the GOHIBIC arm and 85 deaths in the placebo arm [see Clinical Studies (14)]. Fatal infections occurred in more placebo patients. Nonfatal serious infections occurred in 58 patients (33.1%) in the GOHIBIC arm and in 55 patients (29.1%) in the placebo arm. The most commonly reported nonfatal serious infections with GOHIBIC were pneumonia (18.9% vs 13.8% in placebo), sepsis (14.9% versus 7.4% in placebo), and septic shock (9.1% versus 7.4% in placebo).
Discontinuation of study treatment due to an adverse reaction occurred in 2.9% of the GOHIBIC group and 1.6% of the placebo group. Adverse reactions leading to discontinuation of GOHIBIC included eczema, bronchopulmonary aspergillosis, rash, hemodynamic instability, thrombocytopenia, and multi-organ failure.
The most common adverse reactions occurring in at least 3% of GOHIBIC-treated patients and at least 1% more frequently than observed in the placebo arm are summarized in Table 1.
Table 1. Adverse Reactions that Occurred in ≥3% of Patients Treated with GOHIBIC and at least 1% More Frequently than Observed in the Placebo Arm through Day 60 Adverse Reactions GOHIBIC + SoC (N=175) Placebo + SoC (N=189) n (%) n (%) SoC = standard of care. A patient is only uled once (regardless of event numbers) but one patient can be uled in different categories with one or additional reactions Pneumonia "Pneumonia" includes preferred terms containing the term "pneumonia"; does not include "COVID-19 pneumonia" 55 (31.4%) 44 (23.3%) Sepsis "Sepsis" includes preferred terms containing the term "sepsis". 38 (21.7%) 30 (15.9%) Delirium "Delirium includes the following preferred terms: Delirium, Intensive care unit delirium 22 (12.6%) 20 10.6%) Pulmonary embolism 19 (10.9%) 17 (9.0%) Hypertension 16 (9.1%) 13 (6.9%) Pneumothorax 14 (8.0%) 11 (5.8%) Deep vein thrombosis 11 (6.3%) 9 (4.8%) Herpes simplex 11 (6.3%) 5 (2.6%) Enterococcal infection 10 (5.7%) 8 (4.2%) Bronchopulmonary aspergillosis 10 (5.7%) 7 (3.7%) Hepatic enzyme increased 9 (5.1%) 7 (3.7%) Urinary tract infection 9 (5.1%) 6 (3.2%) Hypoxia 8 (4.6%) 6 (3.2%) Thrombocytopenia 8 (4.6%) 2 (1.1%) Pneumomediastinum 8 (4.6%) 0 (0.0%) Respiratory tract infection 7 (4.0%) 5 (2.6%) Supraventricular tachycardia 7 (4.0%) 1 (0.5%) Constipation 6 (3.4%) 3 (1.6%) Rash 6 (3.4%) 0 (0.0%) 6.3 Required Reporting for Serious Adverse Events and Medication Errors
The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events (SAEs)SAEs are defined as: and medication errors potentially related to GOHIBIC within 7 calendar days from the healthcare provider's awareness of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA requires that such reports, using FDA Form 3500, include the following:
- Death;
- A life-threatening AE;
- Inpatient hospitalization or prolongation of existing hospitalization;
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
- A congenital anomaly/birth defect;
- Other important medical event, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly
- Patient demographics and baseline characteristics (e.g., patient identifier, age or date of birth, gender, weight, ethnicity, and race)
- A statement "GOHIBIC use for COVID-19 under Emergency Use Authorization (EUA)" under the "Describe Event, Problem, or Product Use/Medication Error" heading
- Information about the SAE or medication error (e.g., signs and symptoms, test/laboratory data, complications, timing of drug initiation in relation to the occurrence of the event, duration of the event, treatments required to mitigate the event, evidence of event improvement/disappearance after stopping or reducing the dosage, evidence of event reappearance after reintroduction, clinical outcomes).
- Patient's preexisting medical conditions and use of concomitant products
- Information about the product (e.g., dosage, route of administration, NDC #).
Submit AE and medication error reports, using Form 3500, to FDA MedWatch using one of the following methods:
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by:
- Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
- Fax to 1-800-FDA-0178, or
- Call 1-800-FDA-1088 to request a reporting form
In addition, please provide a copy of all FDA MedWatch forms to: InflaRx GmbH Fax: 1-866-728-2630 E-mail: pvusa@inflarx.de Or call InflaRx GmbH at 1-888-254-0602 to report AEs.
The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory responses to requests from FDA for information about AEs and medication errors following receipt of GOHIBIC.
7 Drug Interactions
No drug interaction studies have been conducted with GOHIBIC.
8 Use In Specific Populations
8.1 Pregnancy
Risk Summary
There are no available data on GOHIBIC use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as GOHIBIC is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal (ePPND) study conducted in cynomolgus monkeys, placental transport of GOHIBIC was observed but there was no evidence of fetal harm following intravenous administration of GOHIBIC throughout pregnancy at doses 2.5 times the maximum recommended human dose (MRHD) of 800 mg on a mg/kg basis (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk for major birth defects and miscarriage in clinical recognized pregnancies is 2% - 4% and 15% - 20%, respectively.
Data
Animal Data
In the ePPND study, pregnant cynomolgus monkeys received GOHIBIC from GD20 to GD22 (dependent on pregnancy determination), at the beginning of organogenesis, and once every 7 days until the end of gestation at intravenous doses up to 50.6 mg/kg/wk (2.5 times the MRHD on a mg/kg basis). There were no GOHIBIC-related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development up to 6 months of age (PND183). GOHIBIC crossed the placenta in cynomolgus monkeys and GOHIBIC plasma concentrations were similar in infants relative to maternal animals on PND28 and were 8-12 times higher in infants relative to maternal animals on PND91. GOHIBIC was not detected in infant plasma on PND183.
8.2 Lactation
Risk Summary
There are no available data on the presence of GOHIBIC in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to GOHIBIC are unknown.
The lack of clinical data during lactation precludes clear determination of the risk of GOHIBIC to an infant during lactation. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for GOHIBIC and any potential adverse effects on the breastfed child from GOHIBIC or from the underlying maternal condition.
8.3 Pediatric Use
GOHIBIC is not authorized or approved for the emergency use in pediatric patients for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized patients when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
8.4 Geriatric Use
Of the total number of GOHIBIC-treated patients in clinical studies for COVID-19 receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO), 53 (30%) were >65 years. No overall differences in effectiveness or safety of GOHIBIC have been observed between patients 65 years of age and older and younger adult patients.
11 Description
Vilobelimab is a chimeric human/mouse immunoglobulin G4 (IgG4) antibody consisting of mouse anti-human complement factor 5a (C5a) monoclonal binding sites (variable regions of heavy and light chain regions), and human gamma 4 heavy chain and kappa light chain constant regions. GOHIBIC is composed of 1,328 amino acids, and the glycosylated intact protein has an approximate molecular weight of 149 kDa produced in Chinese Hamster Ovary (CHO) cell line genetically engineered using ribonucleic acid transfer through a retro-vector system.
GOHIBIC (vilobelimab) injection is a clear to slightly opalescent, colorless solution for intravenous infusion after further dilution. GOHIBIC is provided in single-dose vials at a concentration of 200 mg/20 mL (10 mg/mL). Each mL also contains dibasic sodium phosphate (0.97 mg), monobasic sodium phosphate (0.4 mg), polysorbate 80 (0.5 mg), sodium chloride (8.8 mg), and Water for Injection. The pH is 6.6 – 7.3.
12 Clinical Pharmacology
12.1 Mechanism of Action
GOHIBIC is a chimeric monoclonal IgG4-kappa antibody that binds to C5a with a dissociation constant of 9.6pM and blocks its interaction with the C5a receptor. C5a is part of the complement system and is activated as part of the innate immune response initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.
12.2 Pharmacodynamics
The reduction of C5a plasma concentration was evaluated in PANAMO. The median plasma concentrations of C5a at baseline in patients with severe COVID-19 pneumonia requiring IMV or ECMO were elevated and the values were comparable between the GOHIBIC group (118.29 ng/mL) and the placebo group (104.62 ng/mL). In the GOHIBIC group, the median concentrations of C5a decreased to 14.53 ng/mL by Day 8 and remained at approximately this level up to Day 30 after the initiation of treatment. In the placebo group, the median concentrations of C5a remained approximately at the baseline level during the study up to Day 30 after the initiation of the treatment. However, the direct clinical relevance of C5a plasma concentration reduction is unclear.
12.3 Pharmacokinetics
In healthy subjects, following a single intravenous infusion of GOHIBIC ranging from 2 mg/kg to 4 mg/kg, GOHIBIC Cmax showed dose proportionality while the AUC showed greater than dose proportionality. The elimination half-life of GOHIBIC following a 4 mg/kg single intravenous dose in healthy subjects was 95 hours.
Pre-dose plasma samples were collected in patients with severe COVID-19 pneumonia requiring IMV or ECMO. Following intravenous infusion of GOHIBIC 800 mg on Days 1, 2, and 4, the pre-dose geometric mean (geometric CV%) plasma concentration of GOHIBIC on Day 8 was 137.9 µg/mL (51%).
Drug Interaction Studies
No drug interaction studies have been conducted with GOHIBIC.
12.6 Immunogenicity
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the study described below with incidence of anti-drug antibodies in other studies, including those of GOHIBIC or of other vilobelimab products.
In the Phase 3 clinical study, 2 patients developed treatment-induced anti-drug antibodies; one patient in the GOHIBIC group and one patient in the placebo group. The clinical relevance of the presence of anti-drug antibodies is unclear.
13 Nonclinical Toxicology
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been conducted to evaluate the carcinogenic potential of GOHIBIC. The malignancy risk in humans from an antibody that binds C5a, such as GOHIBIC, is currently unknown.
Male and female fertility parameters were evaluated as part of the 13-week and 26-week repeat-dose toxicity studies, respectively. There were no treatment-related changes to sperm morphology, count, or motility in male monkeys administered GOHIBIC for 13-weeks at intravenous doses up to 50.6 mg/kg/week (approximately 2.5 times the MRHD on a mg/kg basis). Following 26-weeks intravenous administration of GOHIBIC, there were no effects on female fertility including menstrual cyclicity identified at doses up to 50 mg/kg/week (approximately 2.5 time the MRHD on a mg/kg basis).
14 Clinical Studies
Clinical data supporting this EUA are based on PANAMO (NCT04333420), a Phase 3, double-blind, randomized, placebo-controlled multicenter trial evaluating GOHIBIC for the treatment of COVID-19 in adult (≥ 18 years) patients requiring IMV or ECMO. The multinational trial was conducted in Europe, Latin America, Russia, and South Africa. Efficacy analyses were based on 368 patients, 177 in the GOHIBIC group and 191 in the placebo group. The mean age of participation was 56 years [range: 22 to 81 years] and 68.5% were male. Common co-existing medical conditions included hypertension (46.2%), obesity (40.8%) and diabetes (29.6%) in the overall study population. All patients were mechanically ventilated and three patients in each arm were on ECMO. Additional demographics and baseline characteristics of patients in PANAMO are provided in Table 2.
Table 2. Demographics and Baseline Characteristics of Patients in PANAMO GOHIBIC + SoC A total of 369 patients were randomized in the trial (178 to GOHIBIC and 191 to placebo), but one patient in the GOHIBIC group was randomized in error and not included in the efficacy analyses. (N=177)Placebo + SoC (N=191) Age Group, n (%)   18 – 39 years 22 (12.4%) 30 (15.7%)   40 – 65 years 102 (57.6%) 103 (53.9%)   > 65 years 53 (29.9%) 58 (30.4%) WHO 8-point ordinal scale score World Health Organization 8-point ordinal scale   6 – Intubation and mechanical ventilation 72 (40.7%) 59 (30.9%)   7 – Ventilation + additional organ support (vasopressors, renal replacement therapy, ECMO) 105 (59.3%) 132 (69.1%) Prior and concomitant medications   Dexamethasone or systemic corticosteroid 176 (99.4%) 188 (98.4%)   Baricitinib 6 (3.4%) 6 (3.1%)   Tocilizumab 30 (16.9%) 31 (16.2%)   Remdesivir 10 (5.6%) 11 (5.8%)
The primary endpoint in the study was time to death through Day 28. The Kaplan-Meier estimated 28-Day mortality rate in the GOHIBIC group was 31.7% and the estimated rate in the placebo group was 41.6%, resulting in a hazard ratio of 0.67 (95% CI [0.48, 0.96], p<0.05, Table 3). Results were similar at Day 60 (Table 3). Mortality through day 28 and 60 in PANAMO are provided in Table 3. The percentage of patients alive and either discharged from the hospital or no longer requiring supplemental oxygen at Day 28 were comparable in the GOHIBIC (35.0%) and placebo (36.1%) groups.
Table 3. Mortality through Day 28 and Day 60 in PANAMO GOHIBIC + SoC (N=177) Placebo + SoC (N= 191) Abbreviations: CI = confidence interval Day 28 Mortality   Number of Deaths 54 77   Percentage with Death Results from Kaplan-Meier estimates. Percentages will not be proportional to the number of deaths divided by the total number of patients due to missing values (8 patients missing mortality status in GOHIBIC + SoC and 9 in placebo + SOC). 31.7% 41.6%   Hazard Ratio Results from Cox proportional hazards regression with treatment and age as covariates. P-values < 0.05. (95% CI)0.67 (0.48, 0.96)   Risk Difference Results based on a logistic regression model with treatment and age as covariates, and missing values handled by multiple imputation. (95% CI)-11.2% (-21.0%, -1.4%)  Day 60 Mortality   Number of Deaths 62 87   Percentage with Death 36.5% 47.2%   Hazard Ratio (95% CI) 0.67 (0.48, 0.93)   Risk Difference (95% CI) -12.2% (-22.0%, -2.4%)
16 How Supplied/storage And Handling
How supplied
GOHIBIC (vilobelimab) 200 mg/20 mL (10 mg/mL) injection is a clear to slightly opalescent, colorless solution in a single-dose vial (NDC 83000-110-04).
STORAGE AND HANDLING SECTION
Storage and Handling
Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
17 Patient Counseling Information
As a healthcare practitioner, you must communicate to the patient and/or caregiver information consistent with the "FACT SHEET FOR PATIENTS AND CAREGIVERS" and provide them with a copy of this Fact Sheet prior to administration of GOHIBIC. However, if providing this information will delay administration of GOHIBIC to a degree that would endanger the life of a patient, then information must be provided to the caregiver as soon as feasible after GOHIBIC administration.
18 Manufacturer Information
Manufactured by InflaRx GmbH, Winzerlaer Street 2, 07745 Jena, Germany.
©2023 InflaRx GmbH. All rights reserved.
Fact Sheet For Patients And Caregivers
Emergency Use Authorization (EUA) of GOHIBIC for Coronavirus Disease 2019 (COVID-19)
You are being given this Fact Sheet because your healthcare provider believes it is necessary to provide you with GOHIBIC (vilobelimab) for the treatment of coronavirus disease 2019 (COVID-19). Taking GOHIBIC may benefit adults in the hospital with COVID-19 who require a machine that helps with breathing (invasive mechanical ventilation) or a machine that adds oxygen to the blood outside the body (extracorporeal membrane oxygenation or ECMO). This Fact Sheet contains information to help you understand the potential risks and potential benefits of receiving GOHIBIC.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make GOHIBIC available for use as a treatment for certain adults with COVID-19 (for more details about EUA please see " What is an Emergency Use Authorization? " at the end of this document). GOHIBIC is not FDA-approved for this use. Read this Fact Sheet for information about GOHIBIC. Talk to your healthcare provider about your options or if you have any questions. It is your choice for you to take GOHIBIC or stop it at any time.
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. People of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.
What are the symptoms of COVID-19?
The symptoms of COVID-19 may include fever, cough, and shortness of breath, which can appear 2 to 14 days after exposure. Serious illness, including breathing problems, can occur and may cause your other medical conditions to become worse.
What is GOHIBIC?
GOHIBIC is an investigational medicine used for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). GOHIBIC is investigational because it is still being studied. GOHIBIC is not FDA-approved to treat COVID-19.
There is limited information known about the safety or effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Available results from clinical trials in adults indicate that treatment with GOHIBIC may decrease the risk of dying in hospitalized adults with COVID-19 when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO. The safety and effectiveness of GOHIBIC have not been studied in children hospitalized with COVID-19.
The FDA has authorized the emergency use of GOHIBIC for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO under an EUA. For more information on EUA, see the " What is an Emergency Use Authorization (EUA)? " section at the end of this Fact Sheet.
What should I tell my healthcare provider before I receive GOHIBIC?
Tell your healthcare provider about all of your medical conditions including if you:
- Have allergies.
- Have an infection other than COVID-19.
- Are pregnant or plan to become pregnant.
- Are breast-feeding or plan to breastfeed.
- Have any serious illnesses.
Tell your healthcare provider about all the medicines you take, including prescription and, over-the-counter medicines, vitamins, and herbal supplements.
How will I receive GOHIBIC?
GOHIBIC is given to you through a vein (intravenous or IV) as an infusion. GOHIBIC will be given up to six doses. The first dose will be given within 48 hours of a tube being inserted (intubation) and a machine to help you breathe (ventilator), this is Day 1. The following administration of GOHIBIC will be given on Days 2, 4, 8, 15, and 22 as long as you are hospitalized [even discharged from the Intensive Care Unit (ICU)].
What are the important possible side effects of GOHIBIC?
GOHIBIC may cause serious side effects, including:
- Serious infections: GOHIBIC is a medicine that affects your immune system. GOHIBIC can lower the ability of your immune system to fight infections other than COVID-19.
- Allergic Reactions: Serious allergic reactions can happen during or after treatment with GOHIBIC. These reactions may be severe or life-threatening. Signs and symptoms of a serious allergic reaction with GOHIBIC may include:
- trouble breathing
- rash
- swelling of your face, eyes, lips mouth, tongue and throat.
The most common side effects of GOHIBIC may include: Lung infection, sepsis, sudden confusion, sudden lung artery blockage, high blood pressure, collapsed lung, venous blood clotting (usually in the leg), herpes infection, certain infections caused by enterococci, urinary tract infection, low blood oxygenation, low platelets, the presence of air in the space in the chest between the two lungs, infection of the respiratory tract, heart arrythmia, constipation, and rash.
What other treatment choices are there?
Olumiant (baricitinib), Actemra (tocilizumab), and Veklury (remdesivir) are FDA-approved medicines for the treatment of COVID-19 in hospitalized patients who require invasive mechanical ventilation or ECMO. Talk with your healthcare provider to see if those therapies are appropriate for you. Like GOHIBIC, FDA may allow for the emergency use of other medicines to treat people in the hospital with COVID-19. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on emergency use of other medicines that are not approved by FDA to treat people in the hospital with COVID-19. Please consult with your healthcare provider on which medicine or combination of medicines might be right for you. Your healthcare provider may talk with you about clinical trials you may be eligible for.
It is your choice to be treated or not to be treated with GOHIBIC. Should you decide not to receive it, it will not change your standard medical care.
What if I am pregnant or breastfeeding?
There is no experience giving GOHIBIC to pregnant women or breastfeeding mothers. GOHIBIC may harm your unborn baby. It is unknown if GOHIBIC passes into your breast milk. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
How do I report side effects or adverse events with GOHIBIC?
Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to InflaRx GmbH by calling 1-888-254-0602.
How can I learn more about COVID-19?
- Ask your healthcare provider
- Visit https://www.cdc.gov/COVID19
- Contact your local or state public health department
What is an Emergency Use Authorization (EUA)?
The United States FDA has made GOHIBIC available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
GOHIBIC, as a treatment for COVID-19 has not undergone the same type of review as an FDA-approved product for this indication. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic.
All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for GOHIBIC as a treatment for certain people with COVID-19 is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).
This Fact Sheet may be updated as new data become available. The most recent version of this Fact Sheet is available at www.gohibic.com.
Manufactured by: InflaRx GmbH Winzerlaer Street 2 07745 Jena Germany
© 2023, InflaRx. All rights reserved. Authorized: 04/2023
Principal Display Panel - 200 Mg/20 Ml Vial Carton
NDC 83000-110-04 Rx-only
GOHIBIC (vilobelimab) injection
200 mg/20 mL (10 mg/mL)
For intravenous infusion after dilution
For use under Emergency Use Authorization
4 x 20 mL single-dose vials-Discard unused portion
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