Roivant Sciences (ROIV) and its partner Priovant Therapeutics have secured FDA approval for Lisraya, a first-in-class oral treatment for the rare autoimmune disease dermatomyositis.
The U.S. Food and Drug Administration approved Lisraya, known generically as brepocitinib, on August 27, 2026, for use in adults with dermatomyositis.
Dermatomyositis is a rare systemic autoimmune disease that causes progressive muscle weakness alongside painful, itchy, and disfiguring skin lesions that can severely reduce quality of life.
Patients have historically relied on therapies originally developed for other diseases, leaving a significant gap in targeted treatment options for this debilitating condition.
Lisraya is a TYK2/JAK1 inhibitor taken once daily as a 30 mg tablet, making it the first and only targeted therapy specifically approved for dermatomyositis.
Pfizer originally developed brepocitinib before licensing it to Priovant Therapeutics in 2021, a joint venture created alongside Roivant following a broader deal struck in 2022.
Priovant CEO Ben Zimmer described the approval as representing “a litany of firsts for dermatomyositis patients,” citing its status as the first oral treatment to target immune pathways linked to the disease.
Zimmer added that the drug delivers skin, muscle, physical function, and steroid-sparing benefits, marking a meaningful shift in how the condition can be managed going forward.
Nikolay Nikolov, M.D., Director of the Office of Immunology and Inflammation at the FDA, said: “For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases.”
The approval was supported by results from the VALOR study, a global Phase 3 trial enrolling 241 participants across 90 sites worldwide over 52 weeks.
In that trial, patients receiving the high dose of brepocitinib achieved a mean Total Improvement Score of 46.5 compared with 31.2 for those receiving placebo, clearing the trial’s primary endpoint.
Lisraya also demonstrated the ability to reduce patients’ reliance on corticosteroids, and in some cases allowed patients to discontinue steroid use entirely.
The FDA granted the application Priority Review status, recognising the VALOR results as the first positive 52-week placebo-controlled trial conducted in dermatomyositis.
Octapharma’s intravenous drug Octagam 10% remains the only other modern, targeted, FDA-approved therapy available for the condition.
Brepocitinib is also being studied across several additional indications, including non-infectious uveitis, cutaneous sarcoidosis, and lichen planopilaris, in ongoing Phase 2 and Phase 3 programmes.
Roivant shares closed up 2% at $37.58 following the announcement, reflecting investor confidence in the newly approved therapy’s commercial potential.