FDA declines Invivyd's request to expand PEMGARDA EUA to COVID-19 treatment; prophylaxis EUA unchanged

Invivyd, Inc.

FDA declined expansion of PEMGARDA EUA for mild-to-moderate COVID-19 treatment in immunocompromised patients with no alternative options.
FDA reasoning: immunobridging must show superior antiviral activity, not just equivalence, to prior mAbs like adintrevimab.
Invivyd provided data showing comparable antiviral activity and predicted clinical efficacy above convalescent plasma.
Existing PEMGARDA EUA for pre-exposure prophylaxis remains in effect; treatment opportunity not in prior financial guidance.

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