The Food and Drug Administration (FDA, by its seal in English) of the EE.UU. revoked the emergency use authorization which allows the experimental therapy of bamlanivimab monoclonal anticoagulants, when administered alone, for the treatment of COVID-19 in moderate adult and pediatric patient care.
Based on its analysis of emerging scientific data, specifically the increase in SARS-CoV-2 viral variants that are resistant to bamlanivimab alone, which results in a mayor’s treatment rate that the FDA determines Beneficial and potential benefits of bamlanivimab, when administered alone, do not exceed the known and potential risks for its authorized use. For this reason, the agency determined that the criteria for the issuance of an authorization were not complied with and had been challenged by the EUA.
The recommendation:
The emergency use authorization will be issued on November 9, 2020 to Eli Lilly and Co. allowing the use of bamlanivimab alone for COVID-19 treatment in moderate adult and pediatric patients (12 years or older weighing less than 40 kg) with positive results in SARS-CoV-2 direct viral tests , and there is a high risk of progressing to the COVID-19 grave and / or hospitalization.
The FDA states that although it is currently seeking authorization, alternative antitumor monoclonal therapies are available, including: REGEN-COV (casirivimab and imdevimab, jointly administered), y bamlanivimab and etesevimab, administered together, for the same usus authorized in advance for bamlanivimab only.
The FDA considers that these alternative monoclonal therapy therapies are currently being used to treat patients with COVID-19 which are in agreement with the authorized indications, based on the information available at this time.