Priovant receives first FDA approval for targeted tablet in dermatomyositis

The FDA has approved Priovant Therapeutics' daily tablet Lisraya (brepocitinib) as the first oral targeted treatment for adults with the rare autoimmune disease dermatomyositis. Supported by Phase 3 VALOR trial data showing significant steroid reduction, the drug carries a standard class-wide boxed warning. Originally licensed from Pfizer in a 2022 spinoff with Roivant Sciences, Lisraya is projected by Leerink Partners to reach $1.8 billion in dermatomyositis sales by 2032.

Lisraya FDA approval dermatomyositis

• ▪The FDA's approval of Lisraya (brepocitinib) grants a broad label for use in all adults with dermatomyositis, regardless of their clinical presentation or prior treatments
• ▪The FDA approved Priovant Therapeutics' daily TYK2/JAK1 inhibitor tablet, Lisraya (brepocitinib), as the first orally available targeted drug for adults with dermatomyositis on August 27, 2026
• ▪Dermatomyositis is a rare autoimmune disease characterized by chronic inflammation, progressive muscle weakness, and skin rashes, affecting approximately one in 100,000 people annually
• ▪Leerink Partners projected that global sales of Lisraya (brepocitinib) for dermatomyositis will reach approximately $49 million in 2027, growing to $1.1 billion in 2029 and $1.8 billion by 2032

VALOR trial steroid reduction

• ▪The FDA approval of Lisraya (brepocitinib) was supported by data from the Phase 3 VALOR study, which showed significantly stronger clinical response than placebo
• ▪In the Phase 3 VALOR study, 45% of dermatomyositis patients taking Lisraya (brepocitinib) stopped steroid treatment entirely, compared to 29% of patients in the placebo group

TYK2/JAK1 inhibitor safety warnings

• ▪Lisraya (brepocitinib) carries a boxed warning for serious infections, malignancy, major adverse cardiovascular events, thrombosis, and death, which Leerink Partners noted is in line with the broader JAK inhibitor class
• ▪Leerink Partners stated that there were no major surprises in the FDA-approved label for Lisraya (brepocitinib)

Cutaneous sarcoidosis Phase 2b

• ▪Priovant Therapeutics is testing Lisraya (brepocitinib) in a Phase 3 study for non-infectious uveitis, with data expected in late 2026, and a Phase 2/3 study for lichen planopilaris
• ▪Priovant Therapeutics is developing Lisraya (brepocitinib) for cutaneous sarcoidosis, with Phase 2b data from the BEACON study in February 2026 showing significant disease activity improvements

Pfizer Roivant licensing deal

• ▪Lisraya (brepocitinib) was originally developed by Pfizer before being licensed to Priovant Therapeutics
• ▪Pfizer licensed Lisraya (brepocitinib) to Priovant Therapeutics as part of a spinoff entity formed with Roivant Sciences in 2022

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