COVID-19 Update: FDA Revoked the EUA for Bamlanivimab When Administered Alone

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

Yesterday (April 20, 2021) I blogged on this FDA announcement.  Later in the day, CMS published a Special Edition – MLN Connects that provides this information:

On April 16, the FDA revoked the Emergency Use Authorization (EUA) for bamlanivimab, when administered alone, due to a sustained increase in COVID-19 viral variants in the U.S. that are resistant to this antibody therapy. The FDA determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks.

Medicare will cover and pay for bamlanivimab, when administered alone, for dates of service from November 10, 2020 – April 16, 2021.

The FDA indicates that alternative monoclonal antibody therapies remain appropriate to treat COVID-19 patients, and health care providers may continue using these authorized therapies when administered together:

  • Casirivimab & imdevimab
  • Bamlanivimab & etesevimab

More Information: