FDA revises EUA on COVID-19 treatment Pemgarda

The US Food and Drug Administration on Monday revised the Emergency Use Authorization (EUA) for Invivyd’s (Nasdaq: IVVD) Pemgarda (pemivibart) to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%.

This revision is based on available information including variant susceptibility to Pemgarda and national variant frequencies. The FDA is proactively incorporating this Limitation of Authorized Use in the event that variants with substantially reduced susceptibility to Pemgarda reach this threshold. Pemgarda remains authorized for emergency use for pre-exposure prevention of COVID-19, consistent with its terms and conditions as detailed in the Letter of Authorization, at this time.

The FDA also added important information to the authorized fact sheets to inform health care providers and individuals receiving Pemgarda of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that have substantially reduced susceptibility to Pemgarda.