FDA Modifies Authorizations for COVID-19 Therapeutics

By Jonathan Springston, Editor, Relias Media

The FDA announced on Monday revisions to the emergency use authorizations (EUA) for two monoclonal antibody treatments that seem less efficacious against the omicron variant of SARS-CoV-2.

Moving forward, the FDA says clinicians should administer the bamlanivimab/etesevimab combination or the REGEN-COV solution (casirivimab and imdevimab) only when it is likely patients are infected with or have been exposed to a variant that is not known for withstanding these treatments.

Last week, an independent national panel of experts recommended against using these two solutions to treat SARS-CoV-2. As the FDA noted when it amended the EUAs this week, almost all current U.S. COVID cases are attributed to omicron, so it is unlikely clinicians will see patients who have been exposed to or infected with any other strain.

Meanwhile, the EUAs for several other therapeutics, including remdesivir and sotrovimab, remain intact because they appear to remain efficacious against omicron. For more on sotrovimab, be sure to read the “Pharmacology Update” section in the upcoming February 15 issue of Internal Medicine Alert.