What the FDA decided on Lisraya for Dermatomyositis
The FDA approved Lisraya (brepocitinib) for dermatomyositis. First oral targeted therapy approved for dermatomyositis.
Who the Lisraya decision matters to
Dermatomyositis is a rare autoimmune inflammatory disease causing muscle weakness and distinctive skin rashes, particularly over joints. It involves inflammation of muscles and skin blood vessels.
About 20-30% of adult cases are associated with internal malignancy, making cancer screening essential. Juvenile-onset cases have better prognosis but can cause severe disability.
Prevalence: About 9.6 new cases per million people a year, according to NORD; juvenile-onset incidence about 0.4 cases per 100,000 children. See our full Dermatomyositis page for current treatments, recruiting trials, and community resources.
How Lisraya works
Lisraya: selective TYK2/JAK1 inhibitor that blocks interferon signaling. Our full Lisraya profile covers how it works, side effects in plain language, and its trial history.
Where Dermatomyositis treatment stands today
Read our full Dermatomyositis treatment summary
Treatment options changed in August 2026, when the FDA approved Lisraya (brepocitinib) for adults with dermatomyositis, which the FDA called the first FDA-approved oral treatment option for the disease. Lisraya is a once-daily pill that blocks the TYK2 and JAK1 signaling behind the disease.
In its Phase 3 trial, 55% of patients on Lisraya improved while taking little or no steroid by week 52, against 30% on placebo.
Lisraya carries a boxed warning for serious infections, death, cancer, heart problems, and blood clots, so the decision to use it is one to weigh carefully with a rheumatologist. Octagam 10%, an immune globulin given by IV, has been FDA approved for adults with dermatomyositis since July 2021.
Traditional immunosuppressive combinations including glucocorticoids, methotrexate, azathioprine, and mycophenolate mofetil remain widely used, with trials examining optimal combinations and doses.
Newer biologic therapies targeting B cells, T cells, and complement activation are expanding, offering new hope for patients with refractory disease. Research is ongoing into novel approaches for managing difficult-to-treat cases and improving long-term outcomes while minimizing steroid exposure.
Because adult-onset dermatomyositis can be associated with underlying cancer, screening for malignancy is essential, as is monitoring for pulmonary complications. Consulting with a rheumatologist experienced in myositis ensures comprehensive care addressing skin, muscle, and systemic manifestations.
The Dermatomyositis page has every treatment and trial →Meanwhile, 42 Dermatomyositis studies are open or about to open
The FDA's decision does not end research on Dermatomyositis. Of these, 30 test a treatment; the others follow patients over time. The most recently updated:
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Frequently asked questions
Has the FDA decided on Lisraya?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: FDA press announcement
What was Lisraya approved for?
The FDA approved Priovant Therapeutics' NDA for Lisraya in Dermatomyositis.
What to know: First oral targeted therapy approved for dermatomyositis.
How it works: Selective TYK2/JAK1 inhibitor that blocks interferon signaling.
More: the Lisraya drug page explains it in plain language.
Is there already an FDA-approved treatment for Dermatomyositis?
Yes. Trial Friend's drug list includes 1 FDA-approved drug for Dermatomyositis.
Approved: Lisraya (brepocitinib).
Also coming: Dazukibart, Saphnelo (anifrolumab).
Check: the Dermatomyositis page also searches FDA drug labels for approved treatments.
What did the Lisraya trials show?
The FDA approved Lisraya on August 27, 2026, based on the Phase 3 VALOR trial, a 241-patient study in adults with dermatomyositis. Improvement on the Total Improvement Score showed up as early as week 4 and held through 52 weeks.
More: the Lisraya drug page has the full trial history and sources.
What are the side effects of Lisraya?
Lisraya carries a boxed warning for serious infections, death, cancer, major heart problems (heart attack and stroke), and blood clots, which is standard for this class of medicine. Tell your doctor about any infection, chest pain, shortness of breath, or swelling and pain in a leg.
More: the Lisraya drug page has the label's warnings in full.
How much will Lisraya cost?
Trial Friend does not list a price for Lisraya. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
Drugmaker help: LISRAYA My Compass Support.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Lisraya decision?
The FDA approved Lisraya for Dermatomyositis on August 27, 2026.
Next steps: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
Where this outcome comes from
The outcome on this page comes from FDA press announcement. This page rechecks against our calendar, which is re-verified daily.