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# Expanded Approval for Dupixent in Rhinosinusitis
- URL: https://www.fdaweb.com/expanded-approval-for-dupixent-in-rhinosinusitis/
- Published: 2024-09-13T12:00:00.000Z
- Updated: 2026-09-14T14:41:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157772

FDA has granted expanded approval for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients (aged 12 to 17 years) with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This expands the initial [6/2019](https://www.globenewswire.com/Tracker?data=w90qF6GCmljM0YZvlQbqWrdmYKa6Yk2a2He2kZGHCkM1z8bxT5apbQF0ZFvOlHsJGCzOw4Q18UVvLrraOBhx6pU5SX-1xYJtVuCMBmh2laljyFvc3QLssszKh-HRJ4G9UfRk1kwinnS7Mo6GbRwBGfkjlR6%5FJN1f4TqjudOMQH7-Y%5FO1%5F%5FaC9d4tMQEizUmvdJy6R4Aa9s-yJWfBpdiXVQ==&ref=fdaweb.com) FDA approval in CRSwNP for patients aged 18 years and older.

The approval is based on data from two pivotal trials in adults with inadequately controlled CRSwNP. “In the [SINUS-24 and SINUS-52](https://www.globenewswire.com/Tracker?data=vEjtNeurh8I2gSpCKB8bjaG4D4RqN8JYomLlWeESUtm0aUNrLVsTv4E3b-s9c-dF5qGqSRTypbibuNaYG7u6jBwmUZTnvTJWiSlgh4lEGYuEZXbg3UKwzCsEkG8dOx8r3XVbk2q5kd406FpWqizYaDf0%5FZnEtQK0D1Uiar1dixSZRfDQnVr5HaVMJUr3Wj8PTpt2rab4z8y-peP24ss7SPag5P9sd6KWc4z8N3cPiqI=&ref=fdaweb.com) trials, Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size and sense of smell, while also reducing the need for systemic corticosteroids or surgery at 24 weeks compared to placebo,” the companies say. The expanded use is also supported by pharmacokinetic data from adult and adolescent patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP, along with the safety data of Dupixent in adolescents aged 12 years and older with moderate-to-severe asthma, they add.

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, according to the companies. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.