Industry News Archive

FDA Issues EAU for Monoclonal Antibody to Treat COVID-19

On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody therapy, for the treatment of mild to moderate COVID-19 in adult and pediatric patients who:

  • Have positive results of direct SARS-CoV-2 viral testing
  • Are 12-years-old or older
  • Weigh at least 40 kilograms (about 88 pounds)
  • Are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab has shown through clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment, compared to placebo. As part of the EUA, efficacy of the agent continues to be evaluated and several quality measures have been imposed to protect patients. 

Read the FDA announcement

Posted 11/20/2020

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