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November 10, 2020

Health Law Daily

FDA Authorizes Emergency Use For Eli Lilly’s COVID-19 Antibody Treatment

  • November 10, 2020

Reuters (11/9, Beasley) reports the US Food and Drug Administration (FDA) authorized on Monday emergency use of Eli Lilly’s “COVID-19 antibody treatment for non-hospitalized patients older than 65 or who have certain chronic medical conditions.” The FDA found that clinical trials indicated the treatment, bamlanivimab, “reduced the need for hospitalization or emergency room visits in high-risk COVID-19 patients.”
      The AP (11/9, Perrone) reports the FDA “cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization.” The treatment is administered once by means of an IV.
      CNN (11/9, Fox, Christensen) reports the treatment “must be infused in a hospital or other health care setting” and “is the first monoclonal antibody to be authorized for use in treating coronavirus.”
      The Hill (11/9, Coleman) reports, “Eli Lilly said in a release that bamlanivimab should be given to patients ‘as soon as possible’ after a positive COVID-19 test and within 10 days of the start of symptoms.”
      NBC News (11/10, Edwards) reports that Eli Lilly “has already begun manufacturing the drug, and it said it could have as many as 1 million doses available by the end of the year.”