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Bamlanivimab FDA Approval Status

FDA Approved: No (Emergency Use Authorization)
Generic name: bamlanivimab
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) has issued an Emergency Use Authorization (EUA) 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.

Development Timeline for bamlanivimab

Dec 18, 2020Lilly to Begin Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19 in New Mexico
Dec  4, 2020Lilly and UnitedHealth Group Partner on Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19
Dec  2, 2020Lilly Announces 650,000 Additional Doses of Neutralizing Antibody Bamlanivimab (LY-CoV555) Purchased by U.S. Government to Treat COVID-19
Nov 20, 2020Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives Interim Authorization from Health Canada as a Treatment for COVID-19
Nov  9, 2020Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19
Oct 28, 2020Lilly 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, 2020Data for Lilly's Bamlanivimab (LY-CoV555) in COVID-19 Outpatients Published in New England Journal of Medicine
Oct 26, 2020Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study
Sep 16, 2020Lilly Announces Proof of Concept Data for Neutralizing Antibody LY-CoV555 in the COVID-19 Outpatient Setting
Aug  3, 2020Lilly 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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