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
| Date | Article |
|---|
| Apr 16, 2021 | FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab |
| Apr 16, 2021 | Lilly Requests Revocation of Emergency Use Authorization for Bamlanivimab Alone to Complete Transition to Bamlanivimab and Etesevimab Together for Treatment of COVID-19 in the U.S. |
| Mar 29, 2021 | Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19 |
| Jan 27, 2021 | Lilly, Vir Biotechnology and GSK Announce First Patient Dosed in Expanded BLAZE-4 Trial Evaluating Bamlanivimab (LY-CoV555) with VIR-7831 (GSK4182136) for COVID-19 |
| Jan 26, 2021 | New Data Show Treatment with Lilly's Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent |
| Jan 21, 2021 | Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Prevented COVID-19 at Nursing Homes in the BLAZE-2 Trial, Reducing Risk by up to 80 Percent for Residents |
| Dec 18, 2020 | Lilly to Begin Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19 in New Mexico |
| Dec 4, 2020 | Lilly and UnitedHealth Group Partner on Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19 |
| Dec 2, 2020 | Lilly Announces 650,000 Additional Doses of Neutralizing Antibody Bamlanivimab (LY-CoV555) Purchased by U.S. Government to Treat COVID-19 |
| Nov 20, 2020 | Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives Interim Authorization from Health Canada as a Treatment for COVID-19 |
| Nov 9, 2020 | Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19 |
| Oct 28, 2020 | Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19 |
| Oct 28, 2020 | Data for Lilly's Bamlanivimab (LY-CoV555) in COVID-19 Outpatients Published in New England Journal of Medicine |
| Oct 26, 2020 | Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study |
| Sep 16, 2020 | Lilly Announces Proof of Concept Data for Neutralizing Antibody LY-CoV555 in the COVID-19 Outpatient Setting |
| Aug 3, 2020 | Lilly Initiates Phase 3 Trial of LY-CoV555 for Prevention of COVID-19 at Long-Term Care Facilities in Partnership with the National Institute of Allergy and Infectious Diseases (NIAID) |
Further information
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