FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients

On Monday, the FDA declined Invivyd, Inc.’s IVVD request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for Pemgarda (pemivibart) for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise.

Existing Pemgarda emergency use for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains in effect.

The company said the COVID-19 treatment opportunity for pemivibart was not contemplated in existing financial guidance.

Also Read: What’s Going On With COVID-19 Antibody Developer Invivyd Stock On Friday?

FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and potential benefits of pemivibart…outweigh the known and potential risks”

In the near term, Invivyd plans to share detailed data and regulatory correspondence regarding pemivibart, VYD2311, and the immunobridging of COVID-19 antibodies.

Earlier this month, Invivyd released new data from the ongoing Phase 1/2 trial of VYD2311.

As of Day 65, serum concentrations remain high, potentially substantially increasing the observed half-life of VYD2311 relative to pemivibart, the company's monoclonal antibody medication authorized for the pre-exposure prophylaxis (prevention) of COVID‑19.

Price Action: IVVD stock is down 29.9% at $1.24 during the premarket session on last check Monday.

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