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www.fdanews.com/articles/200306-us-pays-8125-million-for-650000-more-doses-of-eli-lillys-covid-19-antibody

U.S. Pays $812.5 Million for 650,000 More Doses of Eli Lilly’s COVID-19 Antibody

December 4, 2020

The U.S. government is exercising its option for an additional 650,000 doses of Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) for $812.5 million, following the drug’s Emergency Use Authorization (EUA) in November for mild-to-moderately ill COVID-19 patients at high risk.

Doses are to be delivered through the end of January, with “at least” 350,000 of the extra doses delivered this month. The initial deal, struck for $375 million, called for 300,000 vials of 700-mg doses of bamlanivimab delivered through the end of 2020 (DID, Oct. 29).

Under the Operation Warp Speed allocation program, bamlanivimab will be given to patients free of charge via weekly distribution to states and territories based on the number of confirmed COVID-19 cases from the previous seven days.

There has been widespread concern about a possible shortage of the drug. CEO David Ricks reiterated his company’s pledge to make the drug accessible, saying it remains “committed to enabling widespread and equitable access.”

Lilly expects to manufacture up to 1 million 700-mg doses for global use by the end of the year and anticipates a significant increase in production in the first quarter of 2021. But while the FDA’s EUA was for a 700-mg dose, a 2,800-mg dosage was found to be more effective in an interim analysis from a phase 2 trial (DID, Nov. 12).

If the higher dose becomes the preferred treatment, it will make it four times harder for the company to meet the demand. ― Jason Scott