Priovant's Lisraya (Brepocitinib) Approved as First Oral Targeted Therapy for Dermatomyositis
On August 27, 2026, the FDA approved Lisraya (brepocitinib), developed by Priovant Therapeutics Inc. (a Roivant Sciences company), for the treatment of adults with dermatomyositis (DM). Lisraya (30 mg, taken once daily) is a first-in-class TYK2/JAK1 inhibitor and represents the first-ever oral targeted therapy approved specifically for this rare and debilitating systemic autoimmune disease.
Historically, dermatomyositis—characterized by progressive muscle weakness, painful skin rashes, and severe light/touch sensitivity—has been managed off-label with broad immunosuppressants or high-dose corticosteroids. The approval of Lisraya provides a highly anticipated, on-label alternative designed to target the disease's underlying pathogenesis.
The FDA's decision was supported by the landmark Phase 3 VALOR trial (NCT05437263), which enrolled 241 adults with dermatomyositis across 90 sites in 20 countries over 52 weeks. The trial demonstrated durable improvements in muscle strength, skin lesions, and overall disease activity alongside a meaningful reduction in steroid dependency. Like other Janus kinase (JAK) inhibitors, Lisraya carries a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis.
Verbatim Quotes
"Today’s approval of LISRAYA marks a historic moment for the dermatomyositis community and reflects years of extraordinary work and sacrifice by the team at Priovant, our partners, and, above all, the investigators and patients who participated in the brepocitinib development program," said Ben Zimmer, Chief Executive Officer of Priovant.
"For the first time, adults with dermatomyositis have an FDA-approved oral medicine designed to target the disease itself rather than dampen the immune system broadly, after the agency cleared brepocitinib (Lisraya; Roivant) on the strength of phase 3 trial data showing durable improvement in muscle, skin, and overall disease activity alongside meaningful reductions in steroid use." (AJMC)