PARIS (dpa-AFX) - The U.S. Food and Drug Administration has accepted for
Priority Review the supplemental Biologics License Application or sBLA for
Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12
to 17 years with inadequately controlled chronic rhinosinusitis with nasal
polyposis or CRSwNP, Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi said in a
statement.

The target action date for the FDA decision is September 15, 2024. Dupixent is
currently approved as an add-on maintenance treatment for adults with CRSwNP
whose disease is not adequately controlled.

Priority Review is granted to regulatory applications seeking approval for
therapies that have the potential to provide significant improvements in the
treatment, diagnosis or prevention of serious conditions.

If approved, Dupixent would be the first treatment in the U.S. indicated for
adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition
driven in part by underlying type 2 inflammation that obstructs the sinuses and
nasal passages and can lead to a loss of sense of smell, Regeneron said

Regeneron noted that current treatment options for adolescents with CRSwNP leave
many patients with uncontrolled disease and often result in the recurrence of
nasal polyps.

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