Four PDUFA dates on FDA’s February agenda

FDA has set target action dates in February on at least four product applications, including one drug whose approval could put another priority review voucher in play, at a time when the pediatric voucher program’s fate is in limbo.

Mirdametinib, a MAP2K1/2 inhibitor from  Springworks Therapeutics Inc. (NASDAQ:SWTX), has rare pediatric disease designation from FDA and is under priority review to treat neurofibromatosis type 1-associated plexiform neurofibromas. In the pivotal Phase IIb ReNeu study, the therapy led to objective response rates of 52% among 56 pediatric patients, and 41% among 58 adult patients. If approved, it would be the company’s second commercial product after Ogsiveo nirogacestat, which was approved in 2023. Both programs were spun out of Pfizer Inc. (NYSE:PFE) in 2017. ...