04:41 AM EDT, 05/13/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) said Monday the US Food and Drug Administration has accepted for priority review a supplemental biologics license application for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with a type of sinus disease.

The FDA is expected to make a decision on the application by Sept. 15.

Dupixent is already approved as an add-on maintenance treatment for adults with chronic rhinosinusitis with nasal polyposis, the companies said.

The application is based on data from two clinical studies that showed 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 with placebo, Regeneron and Sanofi ( SNY ) said.

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