Dupixent® Approved in U.S. for Adolescents with CRSwNP

Following a Priority Review, Dupixent is now accessible to patients as young as 12 years old dealing with inadequately managed Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). This marks a significant milestone, as conventional treatments often leave numerous patients with unresolved issues, frequently leading to the recurrence of nasal polyps.

Dupixent has emerged as the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions. Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled CRSwNP. This approval builds upon the original FDA approval in June 2019 for patients aged 18 years and older. The FDA's Priority Review designation indicates that this medication could offer significant improvements in efficacy or safety in treating serious conditions.

CRSwNP is a chronic upper airway disease driven partly by type 2 inflammation, obstructing the sinuses and nasal passages. This condition can result in breathing difficulties, nasal congestion and discharge, a reduced or lost sense of smell and taste, facial pressure, sleep disturbance, and a general decline in quality of life. Systemic steroids and surgery are standard treatments but often fail to fully control symptoms or prevent the recurrence of nasal polyps. In the U.S., roughly 9,000 adolescents suffer from inadequately controlled CRSwNP.

George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President, and Chief Scientific Officer at Regeneron, expressed satisfaction with the new approval. "We are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps, which can make their breathing more laborious and difficult, and also deprive them of their sense of smell," he stated. He added that over one million patients globally, from infants to adults, are now being treated with Dupixent across multiple diseases exacerbated by type 2 inflammation.

Brian Foard, Executive Vice President and Head of Specialty Care at Sanofi, emphasized the significance of this approval. "This latest approval for Dupixent marks the first time a biologic is specifically indicated for adolescents with chronic rhinosinusitis with nasal polyps, offering them an option beyond current standard of care."

The FDA’s decision is supported by data from two pivotal trials in adults with inadequately controlled CRSwNP: SINUS-24 and SINUS-52. These trials demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size, and sense of smell while reducing the need for systemic corticosteroids or surgery over 24 weeks compared to a placebo. The approval is also backed by pharmacokinetic data from both adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP, as well as safety data from adolescents aged 12 years and older with moderate-to-severe asthma.

In the SINUS-24 and SINUS-52 trials, the safety profile of Dupixent in adults was generally consistent with the known safety profile in its approved indications. Common adverse events included injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

Dupixent, discovered through 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, which are key drivers of type 2 inflammation in multiple diseases. Regeneron and Sanofi have committed to ensuring that patients in the U.S. who are prescribed Dupixent gain access to the medication through the DUPIXENT MyWay program. Dupixent has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations.

More than one million patients are currently treated with Dupixent globally, underscoring its significant impact on managing these chronic conditions.