Roivant Sciences announced that the U.S. Food and Drug Administration (FDA) has approved LISRAYA™ (brepocitinib) for the treatment of adults with dermatomyositis. The company has initiated the commercial launch of the drug immediately, ahead of its prior guidance.

Key Details

  • Drug & Indication: FDA approval for LISRAYA™, a TYK2/JAK1 inhibitor, for the treatment of adult patients with dermatomyositis.
  • Commercial Launch: The product is commercially available as of August 28, 2026, approximately five weeks ahead of the previously guided launch date of late September 2026.
  • Pricing: The wholesale acquisition cost for LISRAYA™ is set at $35,000 for a 30-count bottle of 30 mg tablets.