FDA approves Roivant's LISRAYA for dermatomyositis, launch begins immediately

The U.S. Food and Drug Administration approved LISRAYA (brepocitinib) 30 mg for the treatment of adults with dermatomyositis, Roivant announced on August 27, 2026.¹ LISRAYA, a first-in-class TYK2/JAK1 inhibitor, is the first and only targeted therapy approved for dermatomyositis.¹

The company said the approval marks the first targeted therapy ever approved for DM, the first once-daily oral therapy for DM, the first therapy shown to provide steroid-sparing benefit alongside disease improvement, and the first therapy to show statistical significance in a 52-week DM-specific trial.²

Approval came ahead of schedule. Prior guidance called for launch by the end of September 2026, but the company said LISRAYA became commercially available today, about five weeks early.²

The approval was based on the Phase 3 VALOR trial. LISRAYA's approval follows the landmark Phase 3 VALOR trial, the largest DM trial ever conducted.¹ On the primary endpoint, mean Total Improvement Score at Week 52 was 46.5 for the 30 mg brepocitinib arm versus 31.2 for placebo (p=0.0006).² Most patients treated with LISRAYA were able to achieve both moderate or better improvement on the Total Improvement Score and minimal or no steroid use by the end of the study (55%, compared to 30% on placebo).¹

Safety findings included serious adverse events in 13 of 81 patients (16%) on 30 mg brepocitinib versus 10 of 79 (13%) on placebo.² The drug carries a boxed warning covering serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.²

On pricing, the filing states the wholesale acquisition cost of LISRAYA is $35,000 for a 30-count bottle of 30 mg tablets.² Regarding ownership, ROIV owns 71% of Priovant, with Pfizer owning 24%, as of June 30, 2026.²