FDA Approves Priovant Lisraya (Brepocitinib) 30 mg for Adult Dermatomyositis, First Oral Targeted Therapy at $35,000 Per Month List Price
Roivant Sciences (NASDAQ: ROIV) subsidiary Priovant Therapeutics announced FDA approval of Lisraya (brepocitinib 30 mg once daily, a first-in-class TYK2/JAK1 dual selective inhibitor) on Wednesday August 27, 2026 for adults with dermatomyositis (DM), an autoimmune inflammatory myopathy with skin involvement and few effective targeted therapies. Approval was based on the 52-week Phase 3 VALOR trial (241 patients, the longest and largest interventional DM study), where 55% of Lisraya patients achieved moderate-or-better improvement on the Total Improvement Score with minimal-or-no steroid use versus 30% on placebo. VALOR results were published in NEJM in March 2026 with dermatology secondary endpoints in JAMA Dermatology in August 2026. List price is $35,000 for a 30-day supply, with a $0/month patient support program for eligible patients. Brepocitinib was originally discovered by Pfizer and licensed to Priovant. Not a peptide; the approval matters here because dermatomyositis is one of several autoimmune indications where peptide immunomodulators (thymalfasin, thymosin alpha-1 analogs) had been discussed in earlier decades before being displaced by targeted small-molecule and biologic approaches.