The FDA has approved Lisraya (brepocitinib) — the first oral, targeted therapy for dermatomyositis, a rare autoimmune disease that causes progressive muscle weakness and painful, itchy skin lesions.
Approved August 27, 2026 and developed by Priovant Therapeutics (a Roivant company), the once-daily pill is a TYK2/JAK1 inhibitor that dampens the overactive immune signaling driving the disease. Until now, patients had no targeted oral option and relied heavily on corticosteroids and broad immunosuppressants.
What the trial showed
Approval rests on the Phase 3 VALOR trial — described as the largest dermatomyositis study conducted. Improvement on the myositis Total Improvement Score appeared as early as week 4 and was sustained through 52 weeks. Key results: 55% of Lisraya patients achieved at least moderate improvement while using minimal or no steroids, versus 30% on placebo. Among those on higher steroid doses at baseline, 45% came off steroids entirely, versus 29% on placebo.
Why it matters — and the safety note
“The approval of Lisraya marks a turning point,” said Harvard’s Dr. Ruth Ann Vleugels, citing the first “targeted, once-daily oral medicine” for the disease. As a JAK-inhibitor-class drug, Lisraya carries a boxed warning for serious infections, mortality, cancer, major cardiovascular events and blood clots — so its use will be weighed against those risks. Still, an effective oral therapy that helps patients taper steroids is a meaningful advance for a disease with few options.