FDA Approves Roivant’s Lisraya (brepocitinib) as First Oral Drug for Dermatomyositis
The U.S. Food and Drug Administration approved Roivant Therapeutics’ Lisraya (brepocitinib) tablets on August 27, 2026, as the first oral drug to treat dermatomyositis in adults. According to the FDA, Lisraya is a first-in-class dual TYK2/JAK1 inhibitor that offers a targeted immunomodulatory therapy for this rare autoimmune disease.
Lisraya (brepocitinib) is the first oral drug approved by the U.S. Food and Drug Administration specifically for the treatment of dermatomyositis in adults, Roivant Therapeutics and its affiliate Priovant Therapeutics announced following the August 27, 2026, approval. The FDA described Lisraya as a first-in-class dual TYK2/JAK1 inhibitor, offering a targeted immunomodulatory therapy for this rare autoimmune disease. Roivant confirmed that the 30 mg once-daily oral tablet is approved for use in the United States immediately, with no restrictions based on disease activity, clinical presentation, or prior treatment experience.
In the 52-week randomized, placebo-controlled trial, adults with dermatomyositis receiving brepocitinib 30 mg daily achieved a mean myositis Total Improvement Score (TIS) of 46.5 compared to 31.2 in the placebo group, a statistically significant difference.
The approval was based primarily on data from the Phase 3 VALOR trial, which is the largest clinical study conducted to date in dermatomyositis patients, according to Priovant. The TIS is a composite measure that evaluates multiple disease domains, including muscle strength, patient and physician global assessments, and skin involvement, officials said. Clinical benefit was evident as early as Week 4 and sustained through Week 52, demonstrating durable efficacy across the disease spectrum.
The VALOR study also highlighted Lisraya’s steroid-sparing effects. Among patients who were on oral corticosteroids at baseline, 62% of those treated with brepocitinib tapered to minimal or no steroid use by Week 52, compared with 38% in the placebo group. Furthermore, 45% of brepocitinib-treated patients fully discontinued corticosteroids by the end of the study versus 29% of placebo patients, according to trial data published in the New England Journal of Medicine and detailed by Priovant. These results underscore the potential for Lisraya to reduce reliance on chronic corticosteroid therapy, which is commonly used but associated with significant side effects.
Dermatomyositis is a rare systemic autoimmune disease characterized by chronic inflammation, progressive muscle weakness, and distinctive skin rashes. It affects an estimated 50,000 Americans, according to coverage of the VALOR trial results. Prior to Lisraya’s approval, treatment options consisted mainly of broad immunosuppressive regimens, including corticosteroids and other systemic agents, with no targeted oral therapies specifically approved for this condition. The Muscular Dystrophy Association welcomed the approval as a milestone, noting it is the first targeted therapy approved specifically for adults with dermatomyositis.
Brepocitinib was developed and is marketed by Priovant Therapeutics, a Roivant-affiliated company focused on autoimmune diseases. Roivant and Priovant announced positive Phase 3 VALOR results on September 17, 2025, and filed a New Drug Application (NDA) with the FDA in the first half of 2026. The FDA accepted the NDA and granted Priority Review, with the Prescription Drug User Fee Act (PDUFA) target action date set for the third quarter of 2026. Following approval, Roivant stated that commercial and manufacturing preparations would scale up immediately, with Lisraya now available for prescription in the U.S. through the company’s enrollment and distribution channels.
Lisraya’s mechanism of action targets the TYK2 and JAK1 signaling pathways implicated in the pathogenesis of dermatomyositis, introducing a novel approach compared with traditional broad immunosuppressants such as corticosteroids and conventional disease-modifying antirheumatic drugs (DMARDs), according to Roivant and regulatory documents. The absence of restrictions in the FDA label suggests broad real-world applicability for adult patients with varying disease severities and clinical presentations.
Analysts and advocacy groups anticipate that Lisraya’s approval will influence future treatment guidelines and standards of care for dermatomyositis. The drug’s designation as the first oral and first targeted therapy for this rare condition marks a significant regulatory and therapeutic development. Roivant and Priovant continue to monitor post-approval outcomes and plan further studies to explore Lisraya’s long-term safety and efficacy profiles.
