麻豆果冻传媒影音

The an emergency use authorization (EUA) for vilobelimab (Gohibic) to treat critically ill adults with COVID-19.

In the EUA for the first-in-class monoclonal anti-human complement factor C5a antibody, the agency specified that the therapy be initiated within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). It is given at a dose of 800 mg administered by intravenous infusion after dilution for a maximum of six doses.

"Today's authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement.

Support for the authorization came from PANAMO, a phase III study that randomized critically ill COVID patients at 46 hospitals across Western Europe, South America, South Africa, and Russia. At 28 days, vilobelimab added to standard of care demonstrated a reduction in all-cause mortality (32% vs 42% for those given placebo plus standard care).

The agency explained in its that vilobelimab "is a recombinant chimeric monoclonal IgG4 antibody that specifically binds to the soluble human complement split product C5a after cleavage from C5 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."

Common adverse events noted in trials included pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, increases in liver enzymes, hypoxia, thrombocytopenia, pneumomediastinum, supraventricular tachycardia, constipation, and rash.

As the drug targets parts of the immune system, the FDA said vilobelimab could lower a patient's ability to fight infections, adding that "serious infections due to bacterial, fungal, or viral pathogens have been reported" in COVID-19 patients receiving the drug. In trials, infections included those of the respiratory or urinary tracts, herpes, enterococcal infection, and bronchopulmonary aspergillosis.

The agency also warned about the risk for serious allergic reactions to the drug.

In a from drugmaker InflaRx, the company said it currently has a supply of vilobelimab available and is "working to ramp up production at its third-party manufacturer to roll out supply in the U.S. as soon as possible."

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