Regeneron Receives EMA’s CHMP Positive Opinion of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending the approval of Dupixent for PN. The EC’s final decision is expected in the coming months
- The opinion was based on the P-III (PRIME & PRIME2) trial evaluating Dupixent vs PBO in 151 & 160 adults patients with uncontrolled PN inadequately controlled with topical prescription therapies or those therapies were not advisable
- The results showed a reduction in itch & skin lesions and an improvement in health-related QoL while reducing skin pain & symptoms of anxiety/depression. The safety results were consistent with the known safety profile of Dupixent in its approved dermatology indication. The therapy was approved in 1+ country globally for AD, PN, asthma, CRSwNP or EoE
Ref: Regeneron | Image: Regeneron
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