FDA approves Lisraya as first oral treatment for adults with dermatomyositis

Priovant’s once-daily JAK/TYK2 inhibitor introduces a new FDA-approved treatment option for the rare autoimmune disease, supported by Phase III evidence of improvements across muscle, skin and physical-function measures.

The US Food and Drug Administration (FDA) has approved Lisraya (brepocitinib) 30 mg tablets for the treatment of dermatomyositis in adults, making it the first FDA-approved oral therapy specifically indicated for the disease.

The approval is supported by a 241-patient Phase III trial in which once-daily Lisraya produced greater improvement in the study’s composite Total Improvement Score at week 52 than placebo and also improved physical function and skin disease activity.

Field	Content
Alert Type	Drug Approval
Drug Name	Lisraya (brepocitinib)
Indication	Treatment of dermatomyositis in adults
Therapy Area(s)	Immunology; Rheumatology; Dermatology; Rare disease
Geography	United States (FDA)
What Happened	On 27 August 2026, the FDA approved Lisraya (brepocitinib) for adults with dermatomyositis. Lisraya is a once-daily oral JAK/TYK2 inhibitor designed to block signalling pathways involved in immune and inflammatory responses. The approval was granted to Priovant Therapeutics and follows FDA Orphan Drug and Priority Review designations. (U.S. Food and Drug Administration)
Why It Matters	Dermatomyositis is a rare autoimmune disease characterised by chronic inflammation, progressive muscle weakness and distinctive skin manifestations. Patients have historically relied substantially on corticosteroids, immunosuppressants and other therapies not specifically approved for the disease. Lisraya therefore provides a specifically approved oral treatment and introduces JAK/TYK2 inhibition as a new therapeutic approach for adult dermatomyositis. (U.S. Food and Drug Administration)
Supporting Context	Approval was supported by a Phase III randomised, double-blind, placebo-controlled study involving 241 adults. Patients received brepocitinib 30 mg, 15 mg or placebo for 52 weeks. The approved 30 mg dose achieved a higher average Total Improvement Score (TIS) at week 52 than placebo, with improvements also observed in physical function and skin disease activity. Patients receiving the 30 mg dose were also more likely to reduce corticosteroid use by week 48. (U.S. Food and Drug Administration)
Safety	Common adverse reactions included upper respiratory tract infection, headache, fatigue, urinary tract infection and nausea. Lisraya carries a boxed warning covering serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events and thrombosis. (U.S. Food and Drug Administration)
Key Takeaway	Lisraya becomes the first FDA-approved oral therapy specifically for adult dermatomyositis, adding a targeted JAK/TYK2 inhibitor to a treatment landscape that has historically depended heavily on corticosteroids and other immunosuppressive approaches.
What to Watch	Uptake of Lisraya in clinical practice, particularly its positioning relative to existing immunosuppressive treatment strategies and whether its ability to reduce corticosteroid use translates into a meaningful longer-term treatment advantage.
Primary Source	US Food and Drug Administration
Relevant Date	27 August 2026

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