U.S. Spends $1.29 Billion on Neutralizing Antibody Therapy

Indiana-based Eli Lilly and Company today announced a $1.29 billion purchase for the neutralizing antibody therapy bamlanivimab with etesevimab by the U.S. government.

As part of the new agreement, Lilly will supply a minimum of 400,000 doses no later than December 31, 2021.

Furthermore, an additional 614,000 doses of bamlanivimab with etesevimab for administration together has been scheduled for delivery no later than January 31, 2022.

This neutralizing antibody therapy is authorized for emergency use to treat mild to moderate COVID-19 or post-exposure prophylaxis of COVID-19 in specific individuals.

This purchase has been supported in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.

Bamlanivimab and etesevimab together have not been approved by the FDA for any use.

It is unknown if bamlanivimab and etesevimab together are safe and effective for the treatment or post-exposure prophylaxis of COVID-19.

Clinical worsening of COVID-19 after administration of bamlanivimab and etesevimab together has been reported. It may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia, fatigue, and altered mental status.

Some of these events required hospitalization. It is unknown if these events were related to bamlanivimab and etesevimab use or were due to the progression of COVID-19.

Moreover, there are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Therefore, Lilly says bamlanivimab and etesevimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Bamlanivimab and etesevimab are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the emergency use authorization unless the authorization is terminated or revoked sooner.

For more information about using bamlanivimab with etesevimab to treat COVID-19, click here or contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921).

Lilly is a global health care leader based in Indianapolis, IN, that unites caring with discovery to create medicines that make life better for people worldwide.