Priovant Therapeutics announced that the U.S. Food and Drug Administration has approved Lisraya (brepocitinib), a first‑in‑class TYK2/JAK1 inhibitor, for the treatment of adults with dermatomyositis. The drug is supplied as a 30 mg oral tablet taken once daily and is now available in the United States through a limited network of specialty pharmacies.
Lisraya had previously earned FDA Priority Review and Orphan Drug Designation. Approval follows the Phase 3 VALOR trial, the largest study of its kind, which enrolled patients for 52 weeks. In the trial, 55% of participants receiving Lisraya achieved a moderate or better improvement on the myositis Total Improvement Score while reducing or eliminating steroid use, compared with 30% on placebo. Among patients starting the study on at least 7.5 mg/day of corticosteroids, 62% on Lisraya tapered to minimal or no steroid use versus 38% on placebo, and 45% discontinued steroids entirely versus 29% on placebo.
The most frequently reported adverse reactions were upper‑respiratory‑tract infection, headache, fatigue, urinary‑tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, falls, influenza and acne. Lisraya carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
Patients eligible for the therapy may qualify for the Lisraya My Compass Support program, which can reduce out‑of‑pocket costs to as low as $0 per month. Priovant, a biotechnology company focused on autoimmune diseases, operates as a Roivant Sciences subsidiary and is headquartered in Durham, North Carolina.
