The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of 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 multicenter, double-blind, randomized, placebo-controlled 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 (ICU). Patients were randomly assigned 1:1 to receive either vilobelimab (n=177) or placebo (n=191), in addition to standard of care (eg, anticoagulants, dexamethasone, other immunomodulators).
Results showed that the Kaplan-Meier estimated 28-day mortality rate (primary endpoint) was 31.7% in the vilobelimab arm compared with 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 200mg/20mL single-dose vial for IV infusion after dilution. The recommended dosage is 800mg 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).
“We are thrilled and very proud that the FDA has issued an EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug,” said Prof. Niels C. Riedemann, CEO and Founder of InflaRx. “Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation. Today’s announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible.”
InflaRx is working to increase 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.
This article originally appeared on MPR