Late-breaking Phase 3 data at AAD 2022 show Dupixent^® (dupilumab) significantly improved signs and symptoms of prurigo nodularis

• Dupixent significantly reduced itch at 12 weeks, and at 24 weeks nearly three times as many Dupixent patients experienced clinically meaningful reductions in itch and skin lesions
• There are currently no approved systemic treatments for prurigo nodularis; regulatory filings for prurigo nodularis planned in the first half of 2022

Paris and Tarrytown, N.Y. March 26, 2022. Detailed positive results from the Phase 3 PRIME2 trial evaluating the safety and efficacy of Dupixent^® (dupilumab) was presented today in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting. The companies previously announced topline results from PRIME2 and a second trial called PRIME investigating the use of Dupixent in adults with uncontrolled prurigo nodularis. In both trials, Dupixent significantly reduced itch and skin lesions compared to placebo. In total, 21 scientific abstracts evaluating the safety and efficacy of Dupixent in patients with atopic dermatitis in different age groups, as well as investigational indications – prurigo nodularis and chronic spontaneous urticaria – will be presented at the congress.

Gil Yosipovitch, M.D.
Professor of Dermatology, Miller School of Medicine, University of Miami, and principal investigator of the PRIME2 trial
“Prurigo nodularis is a relentless and often misunderstood itchy skin disease that leaves many patients with uncontrolled symptoms such as unbearable itch and painful skin lesions, along with a significantly impaired quality of life that should not be underestimated. These positive results are the first time a Phase 3 trial has demonstrated that targeting key drivers of type 2 inflammation, IL-4 and IL-13, with dupilumab significantly improved itch and skin lesions in this highly burdensome disease.“

The randomized, placebo-controlled PRIME2 trial met primary and all key secondary…