U.S. Government Buys $210 Million Additional Neutralizing Antibodies

Indiana-based Eli Lilly and Company announced on February 26, 2021, the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.

Additionally, the US National Institutes of Health updated the COVID-19 Treatment Guidelines to recommend the use of bamlanivimab plus etesevimab for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression.

The U.S. government has said it will provide neutralizing antibodies at no out-of-pocket cost to patients, although healthcare facilities may charge a fee for the product's administration.

This new purchase agreement is for $210 million and doses will be delivered through March 31, 2021. Lilly will begin shipping these additional doses immediately.

The U.S. government has the option to purchase up to an additional 1,100,000 doses through November 25, 2021, under the same terms as the base agreement and subject to agreement from Lilly.

The government has already committed to purchasing a total of 1,450,000 doses of bamlanivimab alone.

"In our clinical trials, Lilly's neutralizing antibody therapies significantly reduced the risk of hospitalizations and death," said David A. Ricks, Lilly's chairman, and CEO, in a press statement.

Bamlanivimab and etesevimab together and bamlanivimab alone are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together or bamlanivimab alone are safe and effective for the treatment of COVID-19.

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