On 27 August 2026, the FDA approved Lisraya (brepocitinib) 30 mg once daily for adults with dermatomyositis. The approval provides a new targeted oral option for a disease that has often required corticosteroids and off-label immunosuppressive treatment.
Why is this approval important?
Dermatomyositis is a rare autoimmune inflammatory disease affecting the skin and muscles. It can cause progressive proximal muscle weakness, characteristic skin disease, impaired physical function and substantial long-term treatment burden.
Lisraya is the first FDA-approved oral treatment specifically indicated for adults with dermatomyositis. It offers a once-daily targeted option that can address both muscle and skin manifestations while supporting corticosteroid reduction.
What is brepocitinib?
Brepocitinib is an oral JAK and TYK2 inhibitor, with greater inhibitory potency for TYK2 and JAK1 than for JAK2 or JAK3 in cell-free assays. These pathways transmit signals from cytokine receptors involved in immune and inflammatory responses.
The FDA-approved dose is 30 mg once daily, with or without food. The label does not recommend combining Lisraya with another JAK inhibitor, another TYK2 inhibitor or a biologic disease-modifying antirheumatic drug.
What evidence supported approval?
The pivotal phase 3 trial was a randomised, double-blind, multicentre, placebo-controlled study in 241 adults with dermatomyositis. Participants could continue stable standard background therapy. The primary endpoint was the mean Total Improvement Score (TIS) at week 52.
| Trial feature | FDA trial |
|---|---|
| Participants | 241 adults |
| Treatment groups | Brepocitinib 30 mg, brepocitinib 15 mg or placebo |
| Treatment period | 52 weeks |
| Primary endpoint | Mean TIS at week 52 |
| Approved dose | 30 mg once daily |
How effective was the approved 30 mg dose?
In the FDA-approved analysis, the least-squares mean TIS at week 52 was 47.5 with Lisraya and 33.3 with placebo—a difference of 14.2 points (95% CI 5.5–22.9).
| Week 52 outcome | Lisraya 30 mg | Placebo |
|---|---|---|
| Least-squares mean TIS | 47.5 | 33.3 |
| TIS ≥20 | 82% | 63% |
| TIS ≥40 | 69% | 47% |
| TIS ≥60 | 48% | 26% |
Major improvement, defined as TIS ≥60, was achieved by 48% of patients receiving Lisraya and 26% receiving placebo. Improvements were also observed in physician and patient global assessments, manual muscle testing, physical function and extramuscular disease activity.
What happened to skin disease and corticosteroid use?
Treatment improved cutaneous disease activity, driven primarily by reduced erythema. The FDA also reported a clinically relevant corticosteroid-sparing effect.
At week 52, 55% of patients receiving Lisraya achieved TIS ≥40 while taking minimal-to-no corticosteroid (≤2.5 mg/day), compared with 30% receiving placebo. Among those taking at least 7.5 mg/day at baseline, 62% vs 38% reached ≤2.5 mg/day at both weeks 48 and 52.
What are the main safety considerations?
Common adverse reactions included upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhoea, back pain, falls, influenza and acne.
Serious infections occurred in 10% of Lisraya-treated patients and 1% of placebo-treated patients during the 52-week trial. Lisraya carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
- Evaluate for active and latent tuberculosis and screen for viral hepatitis before treatment.
- Obtain baseline blood count, hepatic and renal function tests; verify pregnancy status and update immunisations.
- Monitor blood counts, liver enzymes and lipids during treatment.
- Avoid live vaccines and use caution in patients with infection, malignancy, cardiovascular or thrombotic risk.
From evidence to clinical practice
Lisraya expands treatment options for adults with dermatomyositis by providing a targeted, once-daily oral therapy with demonstrated benefits across overall disease activity, muscle function, skin disease and corticosteroid reduction.
The benefit must be balanced against JAK-class safety concerns. Patient selection, pretreatment screening, counselling and longitudinal monitoring remain central to safe use.
Full reference
U.S. Food and Drug Administration. FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults. FDA News Release. 27 August 2026.
LISRAYA (brepocitinib) tablets. U.S. Prescribing Information. Initial U.S. approval 2026. NDA 220106. Revised August 2026.