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FDA approves Roivant's oral therapy Lisraya for rare autoimmune disease

The FDA has approved brepocitinib for dermatomyositis, offering a new oral treatment option for patients with the rare condition.

The short version

  • The FDA approved brepocitinib, brand-named Lisraya, as a once-daily oral treatment for dermatomyositis.
  • Dermatomyositis is a rare autoimmune disease causing muscle weakness and skin rashes, affecting an estimated 40,000 to 70,000 people in the U.S.
  • Developed by Roivant and subsidiary Priovant, the pill offers an alternative to standard treatments relying on high-dose steroids and immunosuppressants.

Key facts

  • The FDA approved Roivant and Priovant's brepocitinib (brand name Lisraya) for dermatomyositis.[STAT]
  • Lisraya is a once-daily oral pill.[STAT]
  • Dermatomyositis is a rare autoimmune disease characterized by painful skin rashes and muscle weakness.[STAT]
  • According to Roivant, dermatomyositis affects between 40,000 and 70,000 people in the United States.[STAT]
  • Standard care for dermatomyositis currently relies on high-dose steroids and immune-suppressing therapies.[STAT]

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