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# Sanofi sBLA for Dupixent in Treating Rhinosinusitis
- URL: https://www.fdaweb.com/sanofi-sbla-for-dupixent-in-treating-rhinosinusitis/
- Published: 2019-03-08T12:00:00.000Z
- Updated: 2026-09-15T01:10:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143567

FDA has accepted for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. Patients with the condition often experience recurrence despite previous treatment with surgery or systemic corticosteroids, the company says. The agency has set a user fee review action target date of 6/26.

The sBLA is supported by data from two pivotal Phase 3 trials. Known as SINUS-24 and SINUS-52, they demonstrated that Dupixent, when added to the standard of care corticosteroid nasal spray, improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes. “In these severe patients, Dupixent reduced the need for systemic corticosteroid use and the need for nasal/sinus surgery,” the company says.

Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 and interleukin-13, which Sanofi describes as two key proteins that may play a central role in type 2 inflammation. It currently is approved for treating adults with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. It is also approved for use with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled on their current asthma medicines.