Bamlanivimab FDA Approval Status
Last updated by Judith Stewart, BPharm on April 18, 2021.
FDA Approved: No (Discontinued)
Generic name: bamlanivimab
Previous name: LY-CoV555
Company: Eli Lilly and Company
Treatment for: COVID-19
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19.
- The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on November 9, 2020 to permit the emergency use of the unapproved product bamlanivimab for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
- On April 16, 2021, the FDA revoked the Emergency Use Authorization that allowed for bamlanivimab when administered alone for the treatment of COVID-19.
- The bamlanivimab and etesevimab combination remains available under EUA.
Development timeline for bamlanivimab
Further information
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