Regeneron COVID-19 Antibody Poised To Add Prevention Claim, Sub-Q Formula
The company is requesting FDA expand the antibody cocktail to include a COVID prevention claim with a lower 1,200mg dose and a subcutaneously administered formula.
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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.
Regeneron reported $2.76bn in revenues from the sale of its COVID-19 antibody cocktail, and that Libtayo in combo with chemotherapy was effective in NSCLC.
AstraZeneca had wanted to outperform Regeneron and Lilly in post-exposure prevention, but will now hope for more durable protection from its long-acting antibody.