Sanofi and Regeneron Announce FDA Approval of Dupixent for Prurigo Nodularis in Adults

Sanofi and Regeneron today announced that the FDA has approved Dupixent (dupilumab) for adults with prurigo nodularis (PN), a chronic skin condition characterized by intensely itchy nodules. This approval makes Dupixent the first biologic approved specifically for PN. In the Phase 3 LIBERTY-PN PRIME and PRIME2 trials, significantly more patients treated with Dupixent achieved the primary endpoint of at least a 4-point improvement in itch intensity and at least 90% reduction in nodule count compared to placebo. Dupixent targets the IL-4 and IL-13 pathways, which are central to type 2 inflammation underlying PN. This approval expands Dupixent's growing portfolio of approved indications.