[co-author: Heather Hatcher, PhD]

Photo by CDC on Unsplash

On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the treatment of mild to moderate COVID-19.[1] Bamlanivimab is the first antibody therapy to treat COVID-19 authorized for emergency use by the FDA. It is an investigational drug that is not currently approved for any indication.

In issuing the emergency authorization, the FDA considered the interim clinical data analysis from an ongoing randomized, double-blind, placebo-controlled, Phase 2 dose-finding trial in outpatients with mild to moderate COVID-19. Bamlanivimab is for use in patients 12 years of age and up who are considered high risk of developing a severe form of the virus, including elderly people and those with certain co-morbidities. The recommended method of administration is infusion within 10 days of the beginning of symptoms.

The antibody therapy, which consists of a neutralizing IgG1 monoclonal antibody that binds to the spike protein of SARS-CoV-2, is aimed at increasing immune response in an effort to reduce viral loads in patients. Those patients with higher viral loads are more likely to suffer complications, including requiring hospitalization. In a press release, Lilly stated that the government has “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.”[2]

Lilly expects to have one million doses of bamlanivimab ready by the end of the year for distribution to healthcare facilities or healthcare providers as directed by the US Government. The EUA will be effective until the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Federal Food, Drug, and Cosmetic Act or the EUA is revoked under Section 564(g) of the Act.

[1] Bamlanivimab EUA Letter of Authorization, November 10, 2020, https://www.fda.gov/media/143602/download

[2] https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda

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