FDA grants emergency use for COVID-19 treatment

FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab (Eli Lilly and Company) to treat mild-to-moderate COVID-19 in adult and pediatric patients.

Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 88 pounds and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

“This includes those who are 65 years of age or older, or who have certain chronic medical conditions,” FDA said in a press release.

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"This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients — adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," said David A. Ricks, Lilly's chairman and CEO, in a press release.

Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, which will distribute it as directed by the U.S. government's allocation program.

The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization, FDA said.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” FDA said.

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"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," said Daniel Skovronsky, MD, PhD, chief scientific officer for Lilly and president of Lilly Research Laboratories.

The frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported, and the EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. “Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers.

For information regarding access to bamlanivimab, patients should speak with their health care providers, and health care providers should contact their state health department directly, Lilly said.

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