FDA authorizes emergency use of casirivimab, imdevimab for COVID-19
The FDA granted emergency use authorization for the monoclonal antibodies casirivimab and imdevimab to be administered together intravenously for the treatment of mild to moderate COVID-19.
According to a press release, this EUA pertains to adults and children aged 12 years and older with positive SARS-CoV-2 viral test results who weigh 88 pounds or more and are at high risk for progressing to severe COVID-19. Adults aged older than 65 years who have certain chronic medical conditions may also receive the treatment. The authorization does not extend to patients who are hospitalized or require oxygen therapy due to COVID-19.
The Washington Post reported that the combination of casirivimab and imdevimab (Regeneron Pharmaceuticals) is the same treatment that President Donald J. Trump received earlier this year after he tested positive for COVID-19.
According to the release, the EUA for casirivimab and imdevimab is based on a randomized, double-blind, placebo-controlled clinical trial of 799 nonhospitalized adults with mild to moderate COVID-19 symptoms. The FDA said the “most important evidence” to emerge from the trial was that only 3% of the monoclonal antibody recipients were hospitalized or visited an ED compared with 9% of those who received placebo. The agency also noted that viral load reduction in patients who were treated with casirivimab and imdevimab was larger compared with patients treated with placebo at day 7. The effects on viral load, reduction in hospitalizations and ED visits were similar in patients receiving either of the two casirivimab and imdevimab doses in the study.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system.”
The combination of casirivimab and imdevimab is the second monoclonal antibody treatment for COVID-19 that the FDA has authorized in less than a month. On Nov. 10, the FDA granted an EUA for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab to treat mild-to-moderate COVID-19 in the same group of patients who are covered in the EUA for casirivimab and imdevimab.
McGinley L and Johnson CY. Experimental drug given to Trump to treat covid-19 wins FDA clearance. https://www.washingtonpost.com/health/2020/11/21/regeneron-fda-clearance/. Accessed November 23, 2020.