Lisraya (brepocitinib) for Dermatomyositis
What is being decided
Priovant Therapeutics has a NDA under FDA review 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
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, 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.
Meanwhile, 55 Dermatomyositis trials are recruiting
Whatever the FDA decides here, research on Dermatomyositis does not stop. A few currently enrolling studies, US sites first:
Other drugs Trial Friend tracks for Dermatomyositis
Get notified when new dermatomyositis trials open or existing trials change status, add sites, or update eligibility.
Frequently asked questions
When will the FDA decide on Lisraya?
The FDA has already decided: the application was approved. See the outcome details above.
What is Lisraya being reviewed for?
Priovant Therapeutics submitted a NDA for Lisraya in Dermatomyositis. First oral targeted therapy approved for dermatomyositis.
What happens after the Lisraya decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from CheckRare. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.