The biotech announced yesterday it had sent its request to the US Food and Drug Administration (FDA) for its combination of two monoclonal antibodies (REGN10933 and REGN10987) which has been designed to block infectivity of SARS-CoV-2.
The antibody cocktail was given to Trump on Friday as part of his treatment for COVID-19. The company has doses available for around 50,000 patients at this time, with the ability to scale this up to 300,000 within the coming months.
Regeneron is already part of Operation Warp Speed: having announced a $450m manufacturing and supply agreement with BARDA and the U.S. Department of Defense for the antibody cocktail in July.
If an EUA is granted, the terms of that agreement state that the government will make these doses available in America at no cost and would be responsible for distribution.
In August, Regeneron announced a partnership with Roche, with each company dedicating manufacturing capacity to REGN-COV2.
Roche will be primarily responsible for securing regulatory approvals outside the US, starting with the European Medicines Agency, and will also take on responsibility for distribution outside the US.
Eli Lilly requests EUA for monotherapy antibody to FDA
Yesterday Eli Lilly also announced it has submitted an initial request for EUA to the FDA for its LY-CoV555 monotherapy.
LY-CoV555 is a neutralizing 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 preventing and treating COVID-19.
Lilly plans on submitting a subsequent request for EUA for combination therapy in November; with hopes to submit a biologics license application (BLA) 'as early as Q2 2021'.