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AUGUST 28, 2024

FDA Would Reduce Use of Pemgarda if It Becomes Less Effective


Originally published by our sister publication Infectious Disease Special Edition

By IDSE News Staff

The FDA revised the emergency use authorization for the monoclonal antibody pemivibart (Pemgarda, Invivyd) to limit its use if 90% or more of SARS CoV-2 variants are not susceptible to the drug.

At the moment, pemivibart remains authorized for pre-exposure prevention of COVID-19, but the agency said it was proactively incorporating this Limitations of Authorized Use if variants with substantially