FDA approves Roivant's brepocitinib for rare autoimmune disease dermatomyositis

On Thursday the U.S. Food and Drug Administration gave its nod to a new therapy from Roivant Sciences and its subsidiary Priovant. The oral medication, brepocitinib, will be sold under the brand name Lisraya and is indicated for dermatomyositis, a rare autoimmune disorder that causes muscle weakness and a painful skin rash.

Dermatomyositis currently relies on high-dose steroids and other immune-suppressing drugs, which can have significant side effects. Roivant estimates that between 40,000 and 70,000 people in the United States are affected by the condition.

The approval provides patients with a novel, once-daily pill option and represents a strategic milestone for Roivant, expanding its portfolio in rare disease therapeutics.