Sanofi Dupixent recommended for EU approval by CHMP for prurigo nodularis treatment

Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patient's quality of life among inflammatory skin diseases due to the extreme itch it causes. Those with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful – with burning, stinging, and tingling of the skin – and can negatively affect mental health, activities of daily living, and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term.

The positive CHMP opinion is supported by data from two Phase 3 trials, PRIME and PRIME2, showing Dupixent significantly reduced itch (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety/depression. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication. 

The use of Dupixent in adults with moderate-to-severe prurigo nodularis is investigational in the EU and is not yet approved.