Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).

The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24 and SINUS-52) that evaluated the safety and efficacy of Dupixent when added to standard-of-care corticosteroid nasal spray (mometasone furoate) in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids. More than half of these patients (~60%) had comorbid asthma.

The 2 trials met their co-primary endpoints of change from baseline in nasal congestion/obstruction severity and change from baseline in nasal polyps score, as assessed at week 24. The data showed that add-on Dupixent helped improve nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell, and co-morbid asthma outcomes. Treatment with Dupixent also led to a decreased need for systemic corticosteroids and nasal/sinus surgery. The full data were presented at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in February 2019.

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Dupixent, an interleukin-4 receptor alpha antagonist, is already approved  as an add-on maintenance treatment in patients with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma. It is also indicated to treat moderate-to-severe atopic dermatitis in adults who are not adequately controlled with topical prescription therapies or when they are not advisable.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 26, 2019 for the CRSwNP indication.

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