FDA approves Priovant's Lisraya for rare inflammatory disorder dermatomyositis

The FDA has approved Priovant Therapeutics' once-daily pill Lisraya (brepocitinib) for dermatomyositis, a rare inflammatory disease affecting 70,000 Americans. Developed by Roivant Sciences after licensing from Pfizer, Lisraya is the first drug to target both JAK1 and TYK2 proteins. The approval is supported by Phase 3 trial data showing significant skin and muscle improvements. Lisraya is priced at $420,000 annually and carries a class-wide black box safety warning.

Lisraya FDA approval for dermatomyositis

• ▪Roivant Sciences CEO Matt Gline stated that Lisraya's FDA label is broad, permitting its use as a monotherapy or as an add-on to non-targeted drugs
• ▪The U.S. Food and Drug Administration approved Priovant Therapeutics' once-daily pill Lisraya for the treatment of dermatomyositis on August 27, 2026
• ▪Lisraya is immediately available for patients following its regulatory approval on August 27, 2026
• ▪Lisraya has a list price of $35,000 per month, or $420,000 per year, before any discounts or rebates

Dermatomyositis treatment options

• ▪Standard treatments for dermatomyositis have historically been inflammation-reducing steroids, broad immune-suppressing drugs, and intravenous immunoglobulin for severe cases
• ▪Dermatomyositis is a rare immunological disease affecting the skin and muscles that is estimated to affect about 70,000 people in the United States

Brepocitinib JAK1 TYK2 mechanism

• ▪Lisraya, also known as brepocitinib, is a small molecule designed to target and block JAK1 and TYK2, which are proteins that play key roles in inflammation
• ▪Lisraya is the first drug developed to address both JAK1 and TYK2 targets together in a single medicine to treat an underlying driver of dermatomyositis inflammation

Phase 3 clinical trial results

• ▪Common adverse reactions reported in the Phase 3 study of Lisraya included upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea
• ▪Phase 3 clinical trial data for Lisraya were published in March 2026 in the New England Journal of Medicine, with additional skin-specific data published on August 26, 2026, in JAMA Dermatology
• ▪The FDA approval of Lisraya was based on a placebo-controlled Phase 3 study of 241 adults with dermatomyositis, which showed higher average response scores in the Lisraya arm compared to placebo at 52 weeks

Roivant Pfizer licensing deal

• ▪Pfizer had previously advanced Lisraya to Phase 3 testing in dermatomyositis and Phase 2 testing in lupus, though the drug failed a mid-stage lupus trial in 2023
• ▪Roivant Sciences formed its subsidiary Priovant Therapeutics to develop Lisraya after licensing the drug's rights from Pfizer, which retains a 25% equity stake in Priovant

JAK inhibitor safety warnings

• ▪The FDA mandated black box warnings on all JAK inhibitor class drugs following a 2021 post-marketing study of Pfizer's Xeljanz that showed higher risks of cancer and cardiovascular problems
• ▪Lisraya's FDA-approved label carries a black box warning consistent with other drugs in the JAK inhibitor class

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