Dupixent sBLA Gets Priority Review for Chronic Rhinosinusitis With Nasal Polyps Indication

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.

For more information call (800) 633-1610 or visit Dupixent.com.