The US Food and Drug Administration (FDA) has granted emergency use authorization to Gohibic (vilobelimab) for the treatment of COVID-19 in hospitalized adults. The treatment must be started within 48 hours of a patient receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
Vilobelimab is a first-in-class, chimeric monoclonal IgG4-kappa antibody that binds to C5a and inhibits its interaction with the C5a receptor. Higher levels of C5a increase the inflammatory response, which may result in multiorgan failure following COVID-19 activation of the complement system.
The authorization was based on data from the double-blind, randomized phase 3 PANAMO trial (ClinicalTrials.gov Identifier: NCT04333420), which included patients 18 years of age and older with COVID-19 who were receiving IMV in intensive care units (ICUs). Patients were randomly assigned 1:1 to receive either vilobelimab (n=177) or placebo (n=191) in addition to standard care (eg, anticoagulants, dexamethasone, other immunomodulators).
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The Kaplan-Meier estimated 28-day mortality rate (primary endpoint) was 31.7% in the vilobelimab arm and 41.6% in the placebo arm (hazard ratio, 0.67; 95% CI, 0.48-0.96; P <.05), correlating to a 23.9% reduction in risk. Similar results were reported at day 60.
The percentage of patients alive and either discharged from the hospital or no longer requiring supplemental oxygen at day 28 were comparable in the vilobelimab and placebo arms (35.0% vs 36.1%, respectively).
The most common adverse reactions reported with vilobelimab were pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, increased hepatic enzymes, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash. Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving vilobelimab.
Gohibic is supplied as a 200 mg/20 mL single-dose vial for IV infusion after dilution. The recommended dosage is 800 mg administered by IV infusion, given up to 6 times over the treatment period. 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).
InflaRx, the company developing Gohibic, is working to increase the supply of the product in the US as quickly as possible. The company is also discussing next steps with the FDA regarding a biologics license application submission for full approval.
References
InflaRx receives FDA emergency use authorization for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patients. News release. InflaRx N.V. Accessed April 5, 2023. https://www.globenewswire.com/news-release/2023/04/04/2641171/0/en/InflaRx-Receives-FDA-Emergency-Use-Authorization-for-Gohibic-vilobelimab-for-Treatment-of-Critically-Ill-COVID-19-Patients.html
Fact sheet for healthcare providers: Emergency use authorization for Gohibic. Accessed April 17, 2023. https://www.fda.gov/media/166824/download
This article originally appeared on MPR
