Regeneron and Sanofi’s Dupixent Approved for Prurigo Nodularis

Regeneron and Sanofi’s blockbuster drug Dupixent (dupilumab) has received expanded approval from the FDA, this time for the treatment of adult patients with prurigo nodularis, a chronic skin disorder that includes the presence of hard, extremely itchy nodules.

Dupixent, which is also approved for treatment of atopic dermatitis and eosinophilic esophagitis, targets a specific type of immune response, type 2 inflammation.

The expanded approval was based on results from two phase 3 trials in which three times as many participants taking Dupixent experienced a clinically meaningful reduction in itch from baseline at 24 weeks compared with those given a placebo.

The European Medicines Agency is currently reviewing a marketing authorization request for the new indication.