Roivant Sciences (ROIV) FDA announcement summary

Introduction and purpose

• LISRAYA (brepocitinib) received FDA approval as the first modern, targeted, once-daily oral therapy for adults with dermatomyositis (DM), addressing a significant unmet need for this rare autoimmune disease.

• LISRAYA is now available for immediate prescription in the U.S., with commercial launch and prescribing open as of the announcement date.

Details of approval or decision

• LISRAYA is approved for adults with DM, with no restrictions based on disease severity, presentation, or prior treatment history, and can be used as monotherapy or in combination with steroids, DMARDs, or IVIG.

• The approval follows Priority Review and Orphan Drug Designation, recognizing its potential for significant improvement in a serious condition.

• The list price is $35,000 for a 30-day supply, with anticipated net annual revenue per patient in the low to mid $300,000s after adjustments.

Impact on industry and stakeholders

• LISRAYA is the first TYK2/JAK1 inhibitor approved for any indication, introducing a new mechanism of action and representing a landmark milestone for DM patients after decades of failed attempts with other drugs.

• Tens of thousands of US patients may benefit, with a high unmet need for therapies that reduce steroid burden and improve quality of life.

• Patient support programs, including My Compass Support, aim to minimize out-of-pocket costs, with many patients expected to pay $0, and distribution is through a limited specialty pharmacy network.