Priovant wins FDA Priority Review for brepocitinib dermatomyositis NDA

Reuters03-03 20:00

Priovant Therapeutics, an affiliate of Roivant Sciences Ltd., said the FDA has accepted its new drug application for brepocitinib to treat dermatomyositis and granted Priority Review. The FDA set a PDUFA target action date in the third quarter of 2026, and Priovant expects a U.S. launch at the end of September 2026.

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