乌鸦传媒

The FDA authorized use of Regeneron's REGN-COV2 intravenous monoclonal antibody cocktail -- now sporting the generic names casirivimab and imdevimab -- for treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, late Saturday.

This emergency use authorization (EUA) was for patients ages 12 and older who tested positive for SARS-CoV-2, as well as adults ages 65 and older with certain chronic medical conditions.

President Trump from COVID-19 after in October.

"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," FDA Commissioner Stephen Hahn, MD, said in announcing the EUA.

Authorization was granted based on data from a randomized phase II/III trial in 799 non-hospitalized adults with mild to moderate COVID-19 symptoms. Over 530 patients received either 2,400 or 8,000 mg of IV casirivimab and imdevimab, while 266 received a placebo within 3 days of a positive SARS-CoV-2 test.

While the trial met its primary endpoint, which was time-weighted average change in viral load from baseline, the FDA characterized the "more important" secondary endpoint of medically attended visits related to COVID-19, particularly hospitalizations and emergency room visits within 28 days. For patients at high risk of disease progression, 3% in the intervention group and 9% in the placebo group had hospitalizations and emergency room visits.

The manufacturer released an interim analysis of the in late September, with data on an additional 524 patients last month.

Fact sheets on dosing instructions, potential side effects and drug interactions will be made available to caregivers. Side effects of casirivimab and imdevimab are standard for biologic drug and may include anaphylaxis, infusion-related reactions, fever, chills, hives, itching and flushing, the agency said.

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