Vilobelimab (Gohibic) was granted Emergency Use Authorization to treat adults hospitalized with severe COVID-19 infection.
This afternoon, the US Food and Drug Administration (FDA) issued emergency use authorization (EUA) to vilobelimab injection for the treatment of COVID-19.
The injectable was granted EUA for use in hospitalized adults, to be initiated within 48 hours of receiving invasive mechanical ventilation or artificial life support (extracorporeal membrane oxygenation).
Vilobelimab is a treatment from the German biotechnology company InflaRx, and will be sold under the brand name Gohibic. Vilobelimab is a first-in-class monoclonal antihuman complement factor C5a antibody.
With this approval, it becomes the first drug authorized to control complement factor C5a, a protein in the immune system associated with the inflammatory response that exacerbates COVID-19 disease progression.
“Today's authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients,” said FDA Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni, MD.
The decision was largely informed by positive phase 3 clinical trial data that found patients treated with vilobelimab had a lowered death risk by days 28 and 60 of treatment, compared to placebo recipients.
The recommended dosage of vilobelimab is 800 mg administered by intravenous infusion after dilution, and administered up to 6 times over the treatment period. The most common adverse reactions to vilobelimab were 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.
Additionally, serious infections due to bacterial, fungal, or viral pathogens have been reported in COVID-19 patients treated with vilobelimab.
The EUA approval means vilobelimab is only available as long as COVID-19 is declared an emergency. InflaRx remains in conversation with the FDA to discuss next steps toward a Biologics License Application (BLA) for full approval.
“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 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.”