USA Changes Neutralizing Monoclonal Antibody Order

Eli Lilly and Company announced on April 12, 2021, the company and the U.S. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on future supplies of bamlanivimab and etesevimab together.

This action terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses scheduled to be delivered to the US government by the end of March 2021, stated Lilly's press release.

Additionally, the bamlanivimab and etesevimab agreement has been modified to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government already purchased.

Lilly's bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Food and Drug Administration (FDA). Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19.

Lilly subsequently developed bamlanivimab and etesevimab for administration together to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone.

Bamlanivimab and etesevimab together and bamlanivimab alone are authorized under an FDA 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.

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