FDA Approves First Oral Targeted Therapy for Dermatomyositis

The FDA has approved brepocitinib (Lisraya) as the first oral, targeted therapy for adult dermatomyositis, demonstrating durable improvement in muscle, skin, and overall disease activity in phase 3 trials. This new medication also significantly reduced steroid use, offering a novel treatment option. However, it carries a boxed warning for serious infections, increased mortality, malignancy, major cardiovascular events, and thrombosis, consistent with other JAK inhibitors.