Indiana-based Eli Lilly and Company announced today a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million.
The existing U.S. government supply of bebtelovimab monoclonal antibodies (mAbs), including the new purchase, is expected to meet present demand through late August 2022.
Delivery of doses will begin immediately and be complete no later than August 5, 2022.
This additional mAbs purchase is supported in whole or in part with federal funds from the Department of Health and Human Services.
As of June 29, 2022, HHS had distributed about 490,081 Bebtelovimab doses in the USA.
On February 11, 2022, Eli Lilly announced an agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab, with an option of 500,000 additional doses for delivery no later than July 31, 2022.
To date, over 700,000 patients have been treated with Lilly's mAbs in the U.S., potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic.
"Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies," said David A. Ricks, Lilly's chair and CEO, in a press release issued on June 29, 2022.
Bebtelovimab is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2.
According to Lilly, Bebtelovimab continues to maintain neutralization activity against the Omicron variants (BA.2.12.1 and BA.4/BA.5) in addition to all known variants of interest and concern.
However, Bebtelovimab has not been approved by the U.S. FDA as of June 29, 2022.
But it has been authorized for emergency use by the FDA under a EUA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
The emergency use of bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologicals.