FDA rescinds Emergency Use Authorization of Eli Lilly’s ‘bamlanivimab’ monoclonal antibody treatment
The FDA has rescinded its Emergency Use Authorization of Eli Lilly’s ‘bamlanivimab,’ the monoclonal antibody treatment for COVID-19, to be used on its own.
The company requested that the treatment have its authorization stripped after new variants prove to be more resistant to the treatment “due to the evolving landscape in the U.S. and the full availability of bamlanivimab and etesevimab together.”
Furthermore, Eli Lilly noted, the request to have authorization revoked was not as a result of any “new safety concern.”
Today, we revoked the emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate #COVID19 in adults and certain pediatric patients. https://t.co/IRmzknz4EH pic.twitter.com/ALedkNpWyl
— U.S. FDA (@US_FDA) April 16, 2021
The cocktail is also used in combination with another Eli-Lilly monoclonal antibody treatment, which the FDA will continue to authorize as it has proven to reduce the risk of death by some 87 percent.
This came after the HHS reported in March they had halted the use of ‘bamlanivimab’ as a solo treatment for COVID-19.