NEWS
Invivyd Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility and PEMGARDA Activity Data
Invivyd (Nasdaq: IVVD) announced that the FDA has updated the Emergency Use Authorization (EUA) Fact Sheet for PEMGARDA™ (pemivibart) with accurate SARS-CoV-2 variant susceptibility data. The updated Fact Sheet, dated September 26, 2024, includes in vitro neutralization activity against dominant circulating variants, including KP.3.1.1 and LB.1, which is in line with prior variants represented in the CANOPY Phase 3 clinical trial.
The FDA removed a contested statement about reduced susceptibility to pemivibart for KP.3.1.1, based on data provided by LabCorp's Monogram Biosciences lab. Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart under industrial-quality conditions for assessing neutralization potency and variant susceptibility.
The FDA removed a contested statement about reduced susceptibility to pemivibart for KP.3.1.1, based on data provided by LabCorp's Monogram Biosciences lab. Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart under industrial-quality conditions for assessing neutralization potency and variant susceptibility.
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