Could REGEN-COV’s New US FDA Emergency Use Authorization Revive COVID-19 Prophylaxis Pipeline?

Regeneron’s neutralizing antibody cocktail earned the first post-exposure prophylaxis EUA for COVID-19, but the new use and dosing improvements need to overcome slow uptake under the original authorization for the COVID-19 treatment and the poisoned environment left by hydroxychloroquine controversies.

Prophylaxis
The post-exposure prophylaxis EUA highlighted the needs of immunocompromised patients, Regeneron's president said. • Source: Alamy

The FDA’s addition of post-exposure prophylaxis for COVID-19 to the emergency use authorization for Regeneron Pharmaceuticals, Inc.’s monoclonal antibody therapy REGEN-COV (casirivimab and imdevimab) on 30 July marks the biggest advance yet for pre- and post-exposure prophylaxis strategies to manage SARS-CoV-2, which aim to reduce the chance that unvaccinated people in close contact with COVID-19 patients will become ill.

The revised EUA clears REGEN-COV for post-exposure prophylaxis in adults and children 12 years and up who weigh at least 40kg and are at high risk for progression to severe COVID-19

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