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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.
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.
There is currently an outbreak of Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2, a novel coronavirus. The Secretary of HHS has:
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:
1 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.
2 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-authorizationdeclaration. 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.”).
Veklury (remdesivir), a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, is an FDA-approved alternative for the treatment of COVID-19 in hospitalized adults 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 for the treatment of COVID-19 in hospitalized adults 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, an interleukin-6 (IL-6) receptor antagonist, is also an FDA-approved alternative for the treatment of COVID-19 in hospitalized adults 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.
The recommended dosage of GOHIBIC for the treatment of adults with COVID-19 is 800 mg administered by intravenous infusion after dilution [see Preparation And Administration ] 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).
Using aseptic technique, dilute and prepare GOHIBIC for intravenous infusion before administration.
200 mg/20 mL (10 mg/mL) clear to slightly opalescent, colorless solution in a single-dose vial.
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).
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.
Manufactured by: InflaRx GmbH, Winzerlaer Street 2, 07745 Jena, Germany. Revised: Apr 2023.
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]. 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]. 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 | (%) | |
| Pneumonia1 | 55 | (31.4%) | 44 | (23.3%) |
| Sepsis2 | 38 | (21.7%) | 30 | (15.9%) |
| Delirium3 | 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%) |
| SoC = standard of care. 1 “Pneumonia” includes preferred terms containing the term “pneumonia”; does not include “COVID-19 pneumonia” 2 “Sepsis” includes preferred terms containing the term “sepsis”. 3 “Delirium includes the following preferred terms: Delirium, Intensive care unit delirium A patient is only listed once (regardless of event numbers) but one patient can be listed in different categories with one or additional reactions |
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The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events (SAEs)* 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:
Submit AE and medication error reports, using Form 3500, to FDA MedWatch using one of the following methods:
In addition, please provide a copy of all FDA MedWatch forms to:
InflaRx GmbH
Fax: 1-866-728-2630
E-mail: [email protected]
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.
*SAEs are defined as:
No drug interaction studies have been conducted with GOHIBIC.
Included as part of the "PRECAUTIONS" Section
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.
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].
Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.
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).
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.
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.
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.
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).
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.
No Information Provided
No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.
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.
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.
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%).
No drug interaction studies have been conducted with GOHIBIC.
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.
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 + SoC1 (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 score2 | ||
| 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%) |
| 1 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. 2 World Health Organization 8-point ordinal scale |
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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) |
|
| Day 28 Mortality | ||
| Number of Deaths | 54 | 77 |
| Percentage with Death1 | 31.7% | 41.6% |
| Hazard Ratio2 (95% CI) | 0.67 (0.48, 0.96) | |
| Risk Difference3 (95% CI) | -11.2% (-21.0%, -1.4%) | |
| Day 60 Mortality | ||
| Number of Deaths | 62 | 87 |
| Percentage with Death1 | 36.5% | 47.2% |
| Hazard Ratio2 (95% CI) | 0.67 (0.48, 0.93) | |
| Risk Difference3 (95% CI) | -12.2% (-22.0%, -2.4%) | |
| Abbreviations: CI = confidence interval 1 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). 2 Results from Cox proportional hazards regression with treatment and age as covariates. P-values < 0.05. 3 Results based on a logistic regression model with treatment and age as covariates, and missing values handled by multiple imputation. |
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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.
