FDA grants Lilly EUA for its COVID-19 mAb

By The Science Advisory Board staff writers

November 10, 2020 -- The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Eli Lilly's investigational monoclonal antibody (mAb) therapy, LY-CoV555 (bamlanivimab), for the treatment of mild to moderate COVID-19 symptoms 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 or older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The agency imposed several quality measures to protect patients, and Eli Lilly is required to implement these quality measures to manufacture the drug under the EUA.

The EUA is based on the FDA's review of the totality of scientific evidence available, and the agency determined that it is reasonable to believe that bamlaniviamab may be effective in treating nonhospitalized patients with mild to moderate COVID-19. Bamlanivimab was evaluated in Blaze-1, a randomized, double-blind, placebo-controlled phase II 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.

The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by healthcare providers. Possible side effects of bamlanivimab include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.

Bamlanivimab remains an investigational drug and has not been approved under a biologics license application (BLA). Evaluation of its safety and efficacy is ongoing across a range of patient populations affected by COVID-19. Data from these studies will be used to support a future BLA submission involving bamlanivimab.

The U.S. government has purchased 300,000 doses of bamlanivimab and committed that Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product's administration. The company will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government's allocation program.

Lilly anticipates manufacturing up to 1 million doses of bamlanivimab by the end of 2020 for use around the world through early next year. Beginning in early 2021, the supply of Lilly's antibody therapy is expected to increase substantially, as additional manufacturing resources come online throughout the year.

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