FDA Authorizes Use of Regeneron Monoclonal Antibody Treatment for COVID-19
MONDAY, Nov. 23, 2020 -- A combination of two monoclonal antibodies was granted emergency use authorization (EUA) for the treatment of mild-to-moderate COVID-19, the U.S. Food and Drug Administration announced Saturday.
The combination of casirivimab and imdevimab, which must be administered together by intravenous infusion, is approved for use in treating patients ages 12 years and older and weighing at least 88 lb who have a high risk for progressing to severe COVID-19 (i.e., those ages 65 years and older and those with certain chronic medical conditions). The EUA does not apply to patients hospitalized with COVID-19 or those requiring oxygen therapy due to COVID-19. The FDA notes that monoclonal antibodies may be tied to worse outcomes for this patient population.
The FDA based its decision to grant the EUA on data from a randomized, double-blind, placebo-controlled clinical trial of 799 nonhospitalized patients with mild-to-moderate COVID-19. Patients were randomly assigned to receive either a single intravenous infusion of 1,200 mg casirivimab and 1,200 mg imdevimab (266 patients), 4,000 mg casirivimab and 4,000 mg imdevimab (267 patients), or placebo (266 patients) within three days of a positive SARS-CoV-2 viral test result. On day 7, patients treated with casirivimab and imdevimab had a larger reduction in viral load. Three and 9 percent of patients who received the antibody treatment and those who received placebo, respectively, were hospitalized or went to the emergency room. The findings were similar between the two doses of casirivimab and imdevimab.
"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," FDA Commissioner Stephen Hahn, M.D., said in a statement.
The EUA was issued to Regeneron Pharmaceuticals Inc.
© 2021 HealthDay. All rights reserved.
Posted: November 2020
Further Support and Information on COVID-19
Read this next
FRIDAY, Jan. 22, 2021 -- Treatment with bamlanivimab and etesevimab, but not monotherapy with bamlanivimab, is associated with a reduction in severe acute respiratory syndrome...
FRIDAY, Jan. 22, 2021 -- There was a decrease in the total number of pediatric emergency department visits in 2020, but the proportion of trauma-related visits increased,...
THURSDAY, Jan. 21, 2021 -- Tocilizumab plus standard care is not superior to standard care alone for improving clinical outcomes among patients with severe or critical COVID-19...
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.