FDA Grants Priority Review Biologics License Application to Dupixent Add-On Maintenance for the Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis

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Regeneron and Sanofi announced that the FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP) and whose condition is inadequately controlled. With the treatment already approved for adults with CRSwNP, the FDA is expected to make a final decision on the sBLA for the expanded indication by September 15, 2024.¹

According to the companies, the application is supported by efficacy data from SINUS-24 and SINUS-52, two trials that showed major improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and a reduction in the need for systemic corticosteroids or surgery. In 2019, Regeneron first released the results of both trials, which evaluated Dupixent 300 mg every two weeks with standard-of-care mometasone furoate nasal spray (MFNS) against placebo injection plus MFNS. Overall, participants in SINUS-24 and SINUS-52 treated with Dupixent experienced a 57% and 51% improvement, respectively in their nasal congestion/obstruction severity compared to a 19% and 15% improvement, respectively, with placebo. Additionally, there was a 33% and 27% reduction, respectively, in nasal polyps scores compared to a 7% and 4% increase, respectively, for placebo.^1,2

"Dupixent is the first biologic therapy to demonstrate the potential to produce disease-modifying effects in severe CRSwNP, significantly improving all disease measures in the study, including sense of smell, one of the most troublesome and challenging-to-treat symptoms for patients," said Claus Bachert, MD, professor, head, clinics, department of otorhinolaryngology at Ghent University, principal investigator of the trials, in a press release. "Patients with comorbid CRSwNP and asthma are often more difficult to treat so it is encouraging that Dupixent, which targets key drivers of type 2 inflammation, may address both conditions in these patients."

Dupixent was first approved by the FDA in March 2017 for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Prior to its first approval, Dupixent was granted Breakthrough Therapy designation in 2014.³

In January, Dupixent was also approved as the first treatment indicated for children over 1 year of age with eosinophilic esophagitis. For this indication, the approval was based on data from the uble-blind, placebo-controlled Phase III Dupixent Pediatric Eosinophilic Esophagitis Trial, which evaluated the efficacy and safety of Dupixent in children up to 11 years of age. In part A, which took place over a 16-week period, the primary endpoint was histological disease remission. Part B went on for 36 weeks, as a continuation from Part A for those eligible, with the same dose level.⁴

“Young children with eosinophilic esophagitis have significant unmet medical needs; despite existing treatment options, 40% of these children in the U.S. under the age of 12 continue to experience symptoms of this disease,” said Namish Patel, MD, head of global development, immunology and inflammation, Sanofi, in a press release. “Today’s approval underscores our commitment to bringing therapies to young patients with unmet needs and also brings hope to these patients who are at a critical age where struggling to eat and maintain weight directly impacts their overall nutritional intake and development.”

References

1. DUPIXENT® (DUPILUMAB) SBLA ACCEPTED FOR FDA PRIORITY REVIEW FOR TREATMENT OF ADOLESCENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS (CRSWNP). Regeneron. May 13, 2024. Accessed May 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-priority-review-0

2. POSITIVE RESULTS PRESENTED FROM TWO PHASE 3 TRIALS OF DUPIXENT® (DUPILUMAB) IN SEVERE CHRONIC RHINOSINUSITIS WITH NASAL POLYPS (CRSWNP). Regeneron. February 25, 2019. Accessed May 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/positive-results-presented-two-phase-3-trials-dupixentr/

3. REGENERON AND SANOFI ANNOUNCE FDA APPROVAL OF DUPIXENT® (DUPILUMAB), THE FIRST TARGETED BIOLOGIC THERAPY FOR ADULTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS. Regeneron. March 28, 2017. Accessed May 13, 2024. https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-sanofi-announce-fda-approval-dupixentr-dupilumab

4. Press Release: Dupixent® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE). Sanofi. January 25, 2024. Accessed May 13, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-01-25-19-30-00-2817342