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February 12, 2021

Health Law Weekly

FDA Authorizes Emergency Use of Monoclonal Antibody Therapy for COVID-19

  • February 12, 2021

The Food and Drug Administration (FDA) issued February 9 an emergency use authorization (EUA) for the two monoclonal antibodies—bamlanivimab and etesevimab—administered in combination to treat patients with mild to moderate COVID-19 outside the hospital setting.

The EUA, which was issued to Eli Lilly & Co., applies to adults, including those 65 years and older, and pediatric patients (12 years or older) who are at high risk for progressing to severe COVID-19.

The treatment is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19, FDA said.

“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research.

According to data from a randomized, double-blind clinical trial of 1,035 non-hospitalized adults at high risk for disease progression, a single intravenous infusion of the monoclonal antibody combination “significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo,” FDA said. The agency added evaluation of the safety and effectiveness of the therapy for treating COVID-19 is ongoing.