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Bamlanivimab and etesevimab FDA Approval Status

FDA Approved: No (Emergency Use Authorization)
Generic name: bamlanivimab and etesevimab
Dosage form: Infusion
Company: Eli Lilly and Company
Treatment for: COVID-19

Bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) are two monoclonal antibodies administered together to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.

  • The bamlanivimab and etesevimab combination received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on February 9, 2021. Bamlanivimab and etesevimab are not FDA approved for any use. It is not known if bamlanivimab and etesevimab are safe and effective for the treatment of COVID-19.
  • The bamlanivimab and etesevimab combination is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older and weighing at least 40 kg who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
  • Bamlanivimab and etesevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

Development Timeline for bamlanivimab and etesevimab

DateArticle
Feb  9, 2021Lilly's Bamlanivimab (LY-CoV555) Administered with Etesevimab (LY-CoV016) Receives FDA Emergency Use Authorization for COVID-19
Jan 26, 2021New 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

Further information

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