Regeneron and Sanofi have received Priority Review from the FDA for their supplemental Biologics License Application (sBLA) seeking approval of Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 with chronic rhinosinusitis with nasal polyposis (CRSwNP) whose condition is inadequately controlled. The FDA is expected to make a final decision on the sBLA by September 15, 2024.
The application submitted by Regeneron and Sanofi for Dupixent’s expanded indication as an add-on maintenance treatment for adolescents with chronic rhinosinusitis with nasal polyposis is substantiated by robust clinical data gleaned from SINUS-24 and SINUS-52 trials. These trials yielded compelling evidence of Dupixent’s efficacy in ameliorating key symptoms associated with chronic rhinosinusitis with nasal polyposis, including significant improvements in nasal congestion/obstruction severity, reduction in nasal polyp size, restoration of sense of smell, and decreased reliance on systemic corticosteroids or surgical interventions.
Dupixent Demonstrates Efficacy in Adolescent Chronic Rhinosinusitis Treatment
Participants who received Dupixent exhibited remarkable enhancements in their CRSwNP symptoms compared to those administered a placebo, indicating the drug’s potential to modify the course of severe CRSwNP. These findings underscore Dupixent’s promising role as a therapeutic option for adolescents grappling with inadequately controlled CRSwNP, offering hope for improved symptom management and enhanced quality of life.
The data gleaned from SINUS-24 and SINUS-52 trials not only elucidate Dupixent’s efficacy but also highlight its capacity to address the underlying pathophysiological mechanisms driving chronic rhinosinusitis with nasal polyposis. By targeting key drivers of type 2 inflammation, Dupixent demonstrates its potential to modulate the disease process and produce comprehensive symptom relief.
The robust clinical evidence supporting Dupixent’s efficacy in CRSwNP underscores the significance of its potential expanded indication, offering healthcare providers a novel therapeutic avenue for managing this debilitating condition in adolescent patients. If granted approval by the FDA, Dupixent would represent a significant advancement in the treatment landscape for chronic rhinosinusitis with nasal polyposis, providing clinicians with a valuable tool for addressing the complex needs of adolescent patients with this chronic and burdensome condition.
Dupixent Pioneers as First Biologic to Modify Disease in Severe Chronic Rhinosinusitis
Dr. Claus Bachert, principal investigator of the trials, emphasized Dupixent’s role as the first biologic therapy to demonstrate disease-modifying effects in severe chronic rhinosinusitis with nasal polyposis, significantly improving all disease measures, including sense of smell, which is often challenging to treat. Dupixent was initially approved by the FDA in March 2017 for adults with moderate-to-severe atopic dermatitis and received Breakthrough Therapy designation in 2014.
In January, Dupixent was also approved as the first treatment for children over 1 year of age with eosinophilic esophagitis, addressing significant unmet medical needs in young patients. This approval underscores the commitment of Regeneron and Sanofi to providing therapies for patients with unmet needs, particularly in critical developmental stages where disease symptoms impact overall health and well-being.
Resource: Regeneron, May 13, 2024
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