FDA greenlight for Roivant’s Lisraya for dermatomyositis

The US Food and Drug Administration (FDA) has approved Roivant (Nasdaq: ROIV) subsidiary Priovant’s Lisraya (brepocitinib) 30mg for the treatment of adults with dermatomyositis (DM). Lisraya is a pill taken once daily.

DM is a rare systemic autoimmune disease characterized by progressive muscle weakness and extensive, painful, and pruritic skin lesions. DM significantly impairs patients’ quality of life through physical disability, pain from both muscle and skin disease, cutaneous disfigurement, skin sensitivity to light and touch, and high levels of dependency on chronic high-dose steroids.