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First Oral Option for Dermatomyositis Gets FDA Green Light

The approval gives adults with dermatomyositis a targeted oral option after a phase 3 trial showed better disease control and lower steroid use.

  • On Thursday, the U.S. Food and Drug Administration approved Lisraya, developed by Roivant and Priovant Therapeutics, as the first targeted oral therapy for dermatomyositis, a rare autoimmune disease causing muscle weakness and skin rashes.
  • Patients with dermatomyositis, which affects between 40,000 and 70,000 people in the U.S., have historically relied on high doses of steroids and other non-specific immune-suppressing drugs, according to Roivant.
  • The drug, a TYK2/JAK1 inhibitor, demonstrated efficacy in a phase 3 trial of 241 adults, with patients receiving 30 mg achieving a mean Total Improvement Score of 46.5 at 52 weeks.
  • Data showed 62% of patients discontinued or tapered steroids, though the treatment carries a boxed warning for serious infections, malignancies, and major adverse cardiovascular events.
  • Dr. Nikolay Nikolov of the FDA called the approval "a meaningful step forward," while the Muscular Dystrophy Association noted the therapy offers a new alternative for patients, with the drug immediately available in the U.S.
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Reuters broke the news in London, United Kingdom on Thursday, August 27, 2026.
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