FDA greenlights first oral therapy for adult dermatomyositis

The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis.

Dermatomyositis is a rare autoimmune condition that attacks muscle and skin, leading to chronic inflammation, weakness and characteristic rashes. Patients have historically had few effective options.

Lisraya is taken once daily and works by inhibiting Janus kinase (JAK) and TYK2 pathways, which are central to the body’s inflammatory response. Blocking these signals helps reduce the muscle and skin damage caused by the disease.

The decision was based on a phase-3, randomized, double-blind, multicenter, placebo-controlled study that demonstrated the drug’s safety and efficacy.