Lisraya (brepocitinib) for Dermatomyositis
What the FDA decided
The FDA approved Priovant Therapeutics's NDA for Lisraya (brepocitinib) in Dermatomyositis. First oral targeted therapy approved for dermatomyositis.
Who this 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: Approximately 1-10 cases per million people; juvenile-onset incidence about 0.4 cases per 100,000 children. See our full Dermatomyositis page for current treatments, recruiting trials, and community resources.
Where Dermatomyositis treatment stands today
Read our full Dermatomyositis treatment summary
The treatment landscape changed in August 2026, when the FDA approved Lisraya (brepocitinib) for adults with dermatomyositis, the first targeted therapy for the disease. It is a once-daily pill that blocks the TYK2 and JAK1 signaling behind the disease, and in its Phase 3 trial most patients improved while also cutting back or stopping steroids.
It 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. 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 trials are recruiting
Whatever the FDA decides here, research on Dermatomyositis does not stop. A few currently enrolling studies, US sites first:
You'll hear about future FDA decisions and new recruiting trials for Dermatomyositis. Unsubscribe anytime.
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's NDA for Lisraya in Dermatomyositis.
What to know: First oral targeted therapy approved for dermatomyositis.
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.
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.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Lisraya decision?
This page updates with the outcome the day it is announced.
If approved: 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.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from FDA press announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.