STAT+: FDA approves Roivant therapy for rare autoimmune disease

The FDA on Thursday approved brepocitinib, developed by Roivant and its subsidiary Priovant, for the treatment of dermatomyositis, a rare autoimmune disease marked by muscle weakness and a painful skin rash. The drug will be marketed under the brand name Lisraya and is taken as a once-daily pill.

Dermatomyositis affects an estimated 40,000 to 70,000 people in the U.S., where the current standard of care relies on high-dose steroids and other immune-suppressing drugs. This approval provides a new, more targeted oral option for patients and represents a significant commercial opportunity for Roivant.