FDA Accepts Dupixent for Priority Review in Adults With Prurigo Nodularis
Dupilumab is under clinical development, and the efficacy and safety have not been fully evaluated by any regulatory authorities.
The FDA has accepted the supplemental biologics license application (sBLA) for dupilumab (Dupixent Medical; Regeneron, Sanofi) for priority review to treat individuals with prurigo nodularis, a chronic skin condition that causes extreme itch and inflammatory skin lesions.1
The target action date for the FDA decision is September 30, 2022.1
The sBLA is supported by data from 2 pivotal phase 3 trials that evaluated the efficacy and safety of dupilumab in adults with prurigo nodularis. Both trials met the primary and key secondary endpoints, showing that dupilumab significantly improved disease signs and symptoms, including reductions in itch and skin lesions compared with the placebo.1
PRIME2 is a placebo-controlled, randomized trial that met its primary and all key secondary endpoints. Approximately 37% of individuals taking dupilumab experienced a clinically meaningful reduction in itch from the baseline compared with approximately 22% of those taking the placebo at week 12.2
Additionally, nearly 3 times as many individuals taking dupilumab experienced a clinically meaningful reduction in itch from the baseline at week 24. Approximately 58% of individuals experienced this reduction compared with 20% who were taking the placebo.2
Furthermore, approximately 45% of individuals taking dupilumab experienced clear or almost clear skin at 24 weeks compared with approximately 16% of individuals who were taking the placebo.2
In the second study, PRIME, more than 3 times of individuals (60%) who were taking dupilumab experienced a clinically meaningful reduction in itching from baseline compared with those (18%) taking the placebo.3
Additionally, approximately 48% of individuals taking dupilumab achieved clear or almost clear skin compared with 18% of individuals taking the placebo.3
Furthermore, individuals who were taking dupilumab experienced significantly greater improvements in measures of health-related quality of life, skin pain, and symptoms of anxiety and depression.3
The safety results from the PRIME2 and PRIME trials were consistent with the known safety profile of dupilumab in its approved dermatology indications.1
The adverse event most commonly observed was conjunctivitis.1
PRIME2 included a total of 160 individuals,2 while PRIME included a total of 151 individuals.3 Both studies included individuals with uncontrolled prurigo nodularis.2
Both studies were part of the LIBERTY-PN PRIME clinical program.2,3
The FDA grants priority review to therapies that have the potential to provide significant improvements in the diagnosis, prevention, or treatment of serious conditions.1
Additional filings around the world are also expected in 2022.1
The potential use of dupilumab in prurigo nodularis is under clinical development, and the efficacy and safety have not been fully evaluated by any regulatory authorities, according to the company.1
References
1. FDA accepts Dupixent (dupilumab) for priority review in adults with prurigo nodularis. Regeneron. News release. May 31, 2022. Accessed May 31, 2022. https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-dupixentr-dupilumab-priority-review-adults-prurigo
2. Late-breaking phase 3 data at AAD 2022 show Dupixent (dupilumab) significantly improved signs and symptoms of prurigo nodularis. Regeneron. News release. March 26, 2022. Accessed May 31, 2022. https://investor.regeneron.com/news-releases/news-release-details/late-breaking-phase-3-data-aad-2022-show-dupixentr-dupilumab
3. Second Positive Phase 2 Dupixent (dupilumab) trial confirms significant improvements for patients with prurigo nodularis. Regeneron. News release. January 19, 2022. Accessed May 31, 2022. https://investor.regeneron.com/news-releases/news-release-details/second-positive-phase-3-dupixentr-dupilumab-trial-confirms
