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March 11, 2019updated 30 Nov 2021 12:01pm

FDA grants priority review for Sanofi’s Dupixent treatment

The FDA has granted priority review for the supplemental biologics licence application of Sanofi’s Dupixent to treat inadequately controlled severe chronic rhinosinusitis with nasal polyps.

The US Food and Drug Administration (FDA) has granted priority review for the supplemental biologics licence application (sBLA) of Sanofi’s Dupixent (dupilumab) to treat inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).

Sanofi is seeking approval for the use of Dupixent as an add-on maintenance therapy for adults with CRSwNP. Patients suffering from severe CRSwNP are known to experience recurrence even after prior treatment with surgery and/or systemic corticosteroids.

CRSwNP is a chronic upper airway disease driven by type 2 inflammation and characterised by polyps blocking the sinuses and nasal passages.

The condition may lead to breathing difficulties, nasal discharge, decrease or outright loss of sense of smell and taste and facial pain or pressure. It currently lacks FDA-approved biologic medicines.

Dupixent is a targeted biologic designed to inhibit signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins that may be involved in type 2 inflammation.

“Patients suffering from severe CRSwNP are known to experience recurrence even after prior treatment with surgery and/or systemic corticosteroids.”

The drug holds the FDA approval for treating adults with moderate-to-severe atopic dermatitis in patients who did not achieve adequate control with or cannot use topical therapies.

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It is additionally approved for conjunctive use with other asthma drugs for the maintenance therapy of moderate-to-severe asthma in people aged 12 years and older whose condition is not controlled on their current medicines.

The application for use in CRSwNP is based on results from two pivotal Phase III clinical trials assessing the safety and efficacy of the drug in combination with standard-of-care corticosteroid nasal spray.

Data showed that the combination improved nasal polyp size, nasal congestion  severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes.

In addition, Dupixent was found to decrease the need for systemic corticosteroid use and nasal/sinus surgery.

Sanofi, in alliance with Regeneron, is further developing dupilumab for a variety of diseases driven by allergic and other type 2 inflammation, such as eosinophilic esophagitis and food allergies.

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