Other Events ·
Roivant Sciences Ltd. announced that the U.S. Food and Drug Administration approved the New Drug Application for…
ROIVRoivant Sciences Ltd.
Roivant Sciences Ltd. announced that the U.S. Food and Drug Administration approved the New Drug Application for LISRAYA (brepocitinib) 30 mg for the treatment of adults with dermatomyositis. Submitted by subsidiary Priovant Therapeutics, Inc., this approval marks the first targeted therapy for this rare autoimmune disease. The decision followed the Phase 3 VALOR trial, which demonstrated significant improvements in skin disease, muscle strength, and physical function alongside substantial steroid-sparing benefits. LISRAYA is available immediately in the U.S. through a limited distribution network of specialty pharmacies. Roivant Sciences Ltd. operates as a biopharmaceutical company that develops and commercializes medicines.