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Aug 28, 2026

FDA approves Priovant's Lisraya for rare inflammatory disorder dermatomyositis

The FDA approved Roivant Sciences subsidiary Priovant Therapeutics' Lisraya as a once-daily pill treatment for dermatomyositis, a rare inflammatory disorder. The drug was licensed from Pfizer.

Aug 28, 2026·3 sources
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Top claims

  • ▪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
  • ▪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
  • ▪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

Topics

FDA drug approval

Related entities

Rare DiseasePfizer

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