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Roivant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S.

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  • The FDA approved LISRAYA (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM), marking the first major therapeutic innovation for this condition in decades.
  • LISRAYA is a once-daily pill that functions as a first-in-class TYK2/JAK1 inhibitor targeting key immune pathways involved in DM pathogenesis.
  • Approval is based on the landmark VALOR Phase 3 trial, the largest dermatomyositis clinical trial ever conducted, which demonstrated robust efficacy across multiple disease activity measures.
  • Patients treated with LISRAYA achieved significant improvements in skin disease, muscle strength, physical function, and overall disease burden compared to placebo.
  • The therapy provides substantial steroid-sparing benefits, with 45% of patients on LISRAYA coming off corticosteroids entirely by the end of the 52-week study versus 29% on placebo.
  • LISRAYA is available immediately in the U.S. through a limited distribution network of specialty pharmacies.
  • Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program, which offers assistance with insurance coverage & financial aid.
  • Common adverse reactions include upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, falls, influenza, & acne.
  • LISRAYA carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), & thrombosis.
  • Roivant will host an investor call on August 28, 2026, at 8:00 a.m. ET to discuss the approval & related updates.
  • The drug is indicated for adult DM patients without restrictions based on disease activity, clinical presentation, or prior treatment experience, & can be used as an alternative or add-on therapy.