Sanofi, Regeneron Pharma announce positive Phase 3 data for Dupixent in adults with uncontrolled prurigo nodularis
People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body.
Tarrytown: Regeneron Pharmaceuticals, Inc. andSanofi have presented detailed positive results from the second of two Phase 3 trials (PRIME) evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis in a late-breaking session at the European Academy of Dermatology and Venereology (EADV) 2022 Congress. These data, which were consistent with the detailed data from the first Phase 3 trial (PRIME2) in prurigo nodularis, show Dupixent significantly reduced itch and skin lesions at 24 weeks.
People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin.
In total, 22 scientific abstracts are being presented at the EADV 2022 Congress discussing Dupixent in atopic dermatitis in patients as young as six months, and its investigational use in chronic spontaneous urticaria and bullous pemphigoid, in addition to prurigo nodularis.
"These positive results from the second of two dupilumab Phase 3 trials in prurigo nodularis confirm inhibiting IL-4 and IL-13 can significantly reduce the unrelenting itch and extensive severe skin lesions that often impair patient quality of life," said Gil Yosipovitch, M.D., Professor of Dermatology at the Miller School of Medicine at University of Miami, Director of the Miami Itch Center and principal investigator of the trial. "In my practice, relieving itch and clearing skin are often the top priorities for my patients across a range of chronic skin diseases. These data demonstrate dupilumab has the potential to address and manage these debilitating symptoms in another chronic skin disease with underlying type 2 inflammation."
The late-breaking data presented at the EADV 2022 Congress are from the randomized, placebo-controlled Phase 3 PRIME trial, which met its primary and key secondary endpoints. At 24 weeks, among patients treated with Dupixent in the trial:
- More than three times as many (60%) experienced a clinically meaningful reduction in itch from baseline, the primary endpoint, compared to placebo patients (18%; p<0.0001).
- Nearly three times as many (48%) achieved clear or almost clear skin, a key secondary endpoint, compared to placebo patients (18%; p=0.0004).
The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indication.
Results from this and an earlier Phase 3 trial, PRIME2, will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis this year. Regulatory submissions are already under review by the European Commission and theU.S. Food and Drug Administration (FDA), with the FDA granting Priority Review in May 2022 and a target action date of September 30, 2022.
The potential uses of Dupixent in prurigo nodularis, chronic spontaneous urticaria and bullous pemphigoid are currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
Dupixent, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.
