Roivant Sciences Ltd (NASDAQ:ROIV) on Thursday secured U.S. Food and Drug Administration approval for LISRAYA (brepocitinib) 30 mg, a once-daily oral medication for adults living with dermatomyositis.

The regulatory decision brings the first and only targeted treatment to market for this rare systemic autoimmune disorder.

Physicians can prescribe the therapy as a standalone option or alongside existing non-targeted therapies, without restrictions regarding prior treatment history or baseline disease severity.

FDA Clearance Expands Dermatomyositis Treatment Options

Dermatomyositis causes progressive muscle weakness, chronic steroid reliance, and painful skin lesions sensitive to light and touch.