Brepocitinib - (VALOR)

Aug. 27, 2026: Priovant Therapeutics announced FDA approval of LISRAYA (brepocitinib) 30 mg, a once-daily TYK2/JAK1 inhibitor, for treatment of adults with dermatomyositis (DM); the drug is available immediately in the U.S. The company says FDA had previously granted Priority Review and Orphan Drug Designation.

Approval was based on the Phase 3 VALOR trial, described as the largest DM trial conducted. Benefits on the primary endpoint, myositis Total Improvement Score, were seen by Week 4 and sustained through 52 weeks. By study end, 55% of LISRAYA-treated patients achieved moderate-or-better improvement plus minimal or no steroid use versus 30% on placebo. Among those taking at least 7.5 mg/day prednisone-equivalent at baseline, 62% tapered to 2.5 mg/day or less versus 38% on placebo, and 45% discontinued corticosteroids entirely versus 29% on placebo. The release also reports benefit on skin disease, muscle strength, patient-rated disease activity, and daily function.

Common adverse reactions in VALOR were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne. Primary VALOR results were published in NEJM in March 2026; additional skin-specific secondary endpoints were published in JAMA Dermatology in August 2026.