European Commission approves Dupixent
as the first and only targeted medicine for prurigo nodularis
Regeneron Pharmaceuticals and Sanofi have announced that the European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation. Its impact on quality of life is one of the highest among inflammatory skin diseases, due to the extreme itchiness it causes. Symptoms include an intense, persistent itch with thick skin lesions (otherwise known as nodules), which can cover most of the body. Although high-potency topical steroids are commonly prescribed, these come with long-term safety risks, and it is estimated that around 70,000 adults living with prurigo nodularis need new treatment options.
The EC’s decision was based on data from two phase 3 trials, PRIME and PRIME2, which evaluated the efficacy and safety of Dupixent®. In these trials, 44% and 37% of patients taking Dupixent® experienced a clinically meaningful reduction in itchiness at 12 weeks, compared to 16% and 22% for the placebo.
The improvement increased at 24 weeks, with approximately three times as many Dupixent® patients experiencing a clinically meaningful reduction in itchiness.
George D Yancopoulos MD PhD, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent, stated: “For the first time, patients with prurigo nodularis in
Europe have a medicine that can help relieve the burden of itchy and painful nodules covering their skin, which can have a devastating impact on their day-to-day lives, both physically and mentally. Dupixent is now approved for its second dermatological disease and fourth disease overall. We remain committed to further investigating this innovative medicine for diseases – such as chronic urticarias and chronic obstructive pulmonary disease – in which type 2 inflammation may play a role.”