Orsini Tapped as Specialty Pharmacy for New Dermatomyositis Therapy

Dermatomyositis is a rare autoimmune inflammatory disease that causes painful skin rashes, muscle weakness, and potential damage to the lungs, heart, and gastrointestinal tract. LISRAYA, or brepocitinib, gained regulatory approval following the VALOR study, which stands as the largest placebo-controlled trial ever conducted for the condition. Data from the study indicated that patients experienced improvements in muscle strength, functional disability, and cutaneous disease, while also reducing the need for steroid interventions.

"The approval of LISRAYA represents an incredible step forward for these patients and their care journey," said Brandon Tom, CEO of Orsini. Priovant Chief Operating Officer Daniel Herz-Roiphe noted that the partnership leverages Orsini’s established experience in rare disease management to provide a seamless access experience for patients. While the drug offers a new therapeutic route, it carries a boxed warning for serious risks, including infections, major adverse cardiovascular events, malignancies, and thrombosis. Patients treated with the therapy require monitoring for potential side effects, and the drug is not recommended for use in combination with other specific immunosuppressive inhibitors.