On Aug. 27, 2026, the FDA approved Roivant/Priovant’s Lisraya™ (brepocitinib) for the treatment of adults with dermatomyositis. Dermatomyositis is a rare systemic autoimmune disease characterized by chronic inflammation that can cause progressive muscle weakness and painful, pruritic skin lesions, often resulting in physical disability and significant impairment in quality of life. Lisraya is a first-in-class oral inhibitor of tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1), immune signaling pathways involved in the inflammation that drives dermatomyositis. It is the first FDA-approved targeted therapy for dermatomyositis. Lisraya carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis associated with JAK inhibitors. The recommended dose is 30mg orally once daily. The therapy is available immediately in the United States through a limited specialty pharmacy network and will cost $35,000 per month. Here is the prescribing information.
At a Glance
- Brand Drug: Lisraya™ (brepocitinib)
- Manufacturer: Roivant/Priovant
- Date Approved: Aug. 27, 2026
- Indication: For the treatment of dermatomyositis in adult patients
- Dosage Forms Available: 30mg tablets
- Launch Date: Upon approval.
- Estimated Annual Cost: $420,000
- FDA Designation: Orphan Drug. Priority Review.
- Dermatomyositis is associated with substantial morbidity and mortality, with an estimated 15% to 40% of patients dying within five years of diagnosis, often due to interstitial lung disease, malignancy, or other severe systemic complications.
- It is estimated to affect approximately 40,000 to 50,000 people in the United States.
- Current treatment typically relies on corticosteroids, immunosuppressants, intravenous (IV) immunoglobulin, and rituximab.
- Approval of Lisraya was based on 55% of patients in the treatment group achieving moderate or greater improvement in disease activity while requiring minimal or no corticosteroid use at 52 weeks, compared with 30% of patients receiving placebo. Among patients receiving at least 7.5mg/day of corticosteroids at baseline, 62% of Lisraya-treated patients reduced steroid use to 2.5mg/day or less by week 52 versus 38% with placebo, while 45% discontinued corticosteroids entirely compared with 29% receiving placebo. Additional benefits were observed across measures of skin disease, muscle strength, physical function, and patient-reported outcomes.
- The most common adverse reactions were upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea.
- Beyond dermatomyositis, Lisraya is also being evaluated in cutaneous sarcoidosis, noninfectious uveitis and lichen planopilaris.
- Pfizer’s dazukibart, an investigational IV interferon-beta inhibitor, is in phase III development for dermatomyositis following phase II results demonstrating improvements in cutaneous disease activity, with potential approval anticipated in 2028.