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Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis
FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026Priority Review supported by
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[{"type":"text","content":"FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositisIf approved, brepocitinib would represent the first targeted therapy approved for dermatomyositis DURHAM, N.C., March 03, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted the application Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. The company expects to launch the drug in the United States at the end of September 2026. The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or effectiveness of the treatment of a serious condition. The Priority Review designation was supported by the significant unmet medical need in dermatomyositis and the results from the Phase 3 VALOR study evaluating brepocitinib in DM. VALOR (N=241) was the longest and largest interventional dermatomyositis trial to date and the first-ever positive 52-week placebo-controlled study in DM. “The dermatomyositis patient and medical communities have been waiting for decades for novel innovative therapeutics that directly target the underlying disease biology, and it is incredibly exciting to have the finish line in sight for the potential first FDA approval of a targeted therapy for this debilitating disease,” said Dr. Ruth Ann Vleugels, M.D., M.P.H., M.B.A., Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Founding Director of the Autoimmune Skin Disease Center and Connective Tissue Disease Clinics at Mass General Brigham and Program Director of the Dermatology-Rheumatology Fellowship at Harvard Medical School. “Dermatomyositis patients are suffering and urgently need better treatment options. The brepocitinib Phase 3 data suggests that this therapy has the potential to meaningfully improve these patients’ quality of life and function with a once-daily oral therapy. I am thrilled regarding this major step forward in our ability to care for our pati...