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Regeneron’s new antibody cocktail drug, REGN-COV2

Reporter : Irina Robu, PhD

Regeneron,  leading biotechnology company using the power of science to bring new medicines to patients in need answered quickly to the COVID-19 pandemic and found an antibody cocktail  as the pandemic numbers increase in the U.S. The antibody cocktail, also known as REGN-COV2 antibody combination therapy is an investigational medicine, and its safety and efficacy have not been fully evaluated by any regulatory authority.

REGN-COV2 is being studied in four ongoing late-stage clinical trials: two Phase 2/3 trials for the treatment of hospitalized and non-hospitalized COVID-19 patients, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient. The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The company expects approval from FDA on its antibody cocktail and expect to have 2.4-gram doses ready for about 80,000 patients at the end of November and 200,000 doses at the beginning of January.  At the same time, Regeneron partnered with Roche to expand its capacity further by increasing its manufacturing capacity.

Regeneron come in COVID-19 research early this year as the outbreak was in its early stages, testing hundreds of virus-neutralizing antibodies in mice and seeing how they compared with antibodies from human survivors of the novel coronavirus.

SOURCE

https://www.fiercepharma.com/manufacturing/regeneron-predicts-300-000-covid-19-cocktail-doses-ready-by-january-and-substantially

 

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