FDA Grants Emergency Authorization For A 2nd COVID-19 Antibody Treatment

One of the experimental drugs that President Trump received while he was battling the coronavirus has been approved for emergency use by the Food and Drug Administration. The drug, made by the biotech company Regeneron, is the second antibody treatment to win emergency use approval from the FDA.

The treatment combines two antibodies — casirivimab and imdevimab — and administers them together by IV. In a clinical trial of about 800 people, the combination was shown to significantly reduce virus levels within days of treatment.

In its authorization on Saturday, the FDA made clear that the drug is only for the treatment of mild to moderate COVID-19 in people 12 years and older who are at high risk of developing more severe symptoms. It's not for patients who are hospitalized because of COVID-19 or who require oxygen therapy because of the virus.

"The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic," said Dr. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research. "We will continue to facilitate the development, evaluation and availability of COVID-19 therapies."