Basel, Switzerland, London, United Kingdom & New York – August 27, 2026
Roivant announced that the U.S. Food and Drug Administration (FDA) approved LISRAYA™ (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM), with the once-daily oral medicine now available in the United States. The approval represents a major regulatory milestone for brepocitinib, which becomes the first targeted therapy approved for dermatomyositis. For cGxP.wire, the key development is the FDA approval and immediate U.S. availability of LISRAYA, expanding Roivant’s commercial portfolio in autoimmune disease and establishing a new targeted treatment option for adults with DM. The approval follows results from the Phase 3 VALOR trial, which evaluated brepocitinib across multiple measures of dermatomyositis disease activity and steroid use.
Roivant Secures FDA Approval for LISRAYA
The FDA approval of LISRAYA covers adults with dermatomyositis without restrictions based on disease activity, clinical presentation or previous treatment experience. Roivant reported that LISRAYA is a once-daily oral TYK2/JAK1 inhibitor designed to target immune pathways involved in dermatomyositis. The regulatory decision follows the VALOR Phase 3 trial, described by the company as the largest clinical trial conducted in dermatomyositis. The study evaluated patients across different background treatment regimens and assessed disease improvement using the myositis Total Improvement Score, alongside measures of skin disease, muscle strength, physical function and overall disease burden. Benefits on the primary endpoint were observed as early as Week 4 and continued through the 52-week study. The approval moves brepocitinib from late-stage clinical development into commercial use in the United States, marking the most important near-term milestone for Roivant’s dermatomyositis program.
LISRAYA Shows Broad Activity in Phase 3 VALOR
Data from the VALOR trial demonstrated treatment benefits across multiple aspects of dermatomyositis, including disease activity and corticosteroid use. At Week 52, 55% of patients receiving LISRAYA achieved moderate or better improvement on the Total Improvement Score together with minimal or no steroid use, compared with 30% receiving placebo. Among patients taking at least 7.5 mg/day of prednisone-equivalent corticosteroids at baseline, 62% reduced steroid use to 2.5 mg/day or less compared with 38% on placebo, while 45% discontinued corticosteroids entirely compared with 29% on placebo. Roivant also reported improvements in skin disease, muscle strength and physical function, with patients receiving LISRAYA reporting substantially greater improvement in their overall perception of disease activity than those receiving placebo. The results provide the clinical foundation for the FDA decision and support the positioning of brepocitinib as a targeted oral treatment for dermatomyositis.
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Roivant Moves LISRAYA Into U.S. Commercial Availability
Following the FDA decision, LISRAYA is immediately available in the United States, with prescriptions submitted through the company’s commercial access system and distribution supported through specialty pharmacies. Roivant’s patient-support program is intended to assist with insurance coverage, financial support and treatment access, with eligible patients potentially receiving the medicine at reduced out-of-pocket cost. The approval also strengthens the broader development strategy for brepocitinib, which remains under investigation in additional immune-mediated diseases, including non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris. However, the immediate commercial significance is the launch of LISRAYA for adult dermatomyositis following the positive Phase 3 development program. Roivant will need to translate the regulatory milestone into sustained patient adoption while continuing to monitor the medicine’s established safety considerations, including serious infections, malignancy, major cardiovascular events and thrombosis associated with the JAK inhibitor class.
Source:Roivant,,press relese
