FDA Grants Emergency Use Authorization to Gohibic for Critically Ill COVID-19 Patients

The FDA has issued an Emergency Use Authorization (EUA) for the monoclonal antibody drug vilobelimab (Gohibic, InflaRx NV) to treat COVID-19 in critically ill patients. The drug may be used in hospitalized adults when initiated within 48 hours of receiving life support through invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).

The FDA granted the EUA based on the PANAMO phase 3 clinical trial results demonstrating that vilobelimab improved survival compared to placebo, with a 23.9% relative reduction in all-cause mortality at 28 days.

“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,” Niels C. Riedemann, MD, PhD, CEO and founder of InflaRx, said in a press release. “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. As a consequence, we continue to see mortality rates in the range of approximately 2000 COVID-19-reported deaths per week as reported by the US Centers for Disease Control and Prevention.”

Vilobelimab has a unique mechanism as the first drug to selectively target and block the activity of complement factor C5a, a protein that plays a powerful and often detrimental role in the body´s inflammatory response. The drug is administered intravenously for a maximum of six 800-milligram doses over the treatment period (days 1, 2, 4, 8, 15, and 22).

The phase 3 trial, published last year in The Lancet Respiratory Medicine, is one of the largest randomized, double-blind, placebo-controlled trials investigating treatments for critically ill, mechanically ventilated patients with COVID-19. Investigators enrolled 369 patients who received either vilobelimab or placebo. All patients also received standard-of-care therapies, including corticosteroids, anticoagulants, and immunomodulators.

Serious treatment-emergent adverse events were reported in 59% of patients in the vilobelimab group versus 63% in the placebo group. The most common adverse effects included pneumonia, sepsis, delirium, pulmonary embolism, high blood pressure, collapsed lung, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, increased liver enzymes, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum (air in the space between your lungs), respiratory tract infection, tachycardia, constipation, and rash.