LISRAYA (brepocitinib) 30 mg
Dermatomyositis · Adults with dermatomyositis
ROIV · Roivant
Regulatory designations
Full timeline
6 milestonesFDA approved LISRAYA for adults with dermatomyositis
FDA approved once-daily oral LISRAYA 30 mg for the treatment of dermatomyositis in adults. FDA described it as the first approved oral treatment option for the disease and confirmed that the application received Priority Review and Orphan Drug designations.
FDA — Approval of LISRAYA for adults with dermatomyositis↗VALOR skin-specific outcomes published in JAMA Dermatology
The publication reported skin-specific secondary outcomes from the Phase 3 VALOR trial, further characterizing the effect of brepocitinib on cutaneous disease activity in adults with dermatomyositis.
Roivant — JAMA Dermatology publication of VALOR skin outcomes↗Phase 3 VALOR results published in NEJM
The peer-reviewed publication reported that brepocitinib 30 mg was superior to placebo on the primary endpoint and all nine key secondary endpoints, including measures of overall disease activity, muscle strength, skin disease, physical function and corticosteroid reduction.
Roivant — NEJM publication of Phase 3 VALOR results↗FDA accepted the NDA with Priority Review
FDA accepted the dermatomyositis NDA and granted Priority Review based on unmet need and the Phase 3 VALOR results.
Roivant — NDA acceptance and Priority Review↗Related News
Roivant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S.
Aug 27, 2026Priovant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S.
Aug 26, 2026JAMA Dermatology Publishes Skin-Specific Outcomes from Phase 3 VALOR Trial Of Brepocitinib in Dermatomyositis
Aug 6, 2026Priovant Announces First Patients Enrolled in Phase 3 Study (BEACON+) of Brepocitinib in Cutaneous Sarcoidosis (CS)
Aug 6, 2026Roivant Reports Financial Results for the First Quarter Ended June 30, 2026, and Provides Business Update