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Regeneron And Sanofi Say FDA Accept For Priority Review SBLA For Dupixent

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

Patients with severe CRSwNP often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids. The target action date for the FDA decision is June 26, 2019.

Currently, there are no FDA-approved biologic medicines to treat CRSwNP, a chronic disease of the upper airway predominantly driven by type 2 inflammation and characterized by polyps that obstruct the sinuses and nasal passages. Patients may experience severe nasal obstruction with breathing difficulties, nasal discharge, reduction or loss of sense of smell and taste, and facial pain or pressure.

Dupixent is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 and interleukin-13 (IL-4 and IL-13). The findings from these trials, as well as from prior trials in atopic dermatitis and asthma, demonstrate that both IL-4 and IL-13 are two key proteins that play a central role in type 2 inflammation, which seems to underlie CRSwNP as well as several other allergic diseases.

In the U.S., Dupixent is approved for treatment of adult patients with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; Dupixent is also approved for use with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. Dupixent is also approved for use in certain adult patients with moderate-to-severe atopic dermatitis in countries of the European Union (EU), and other countries including Canada and Japan.

On March 1, 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the application for Dupixent, recommending its approval in the EU as add-on maintenance treatment for adult and adolescent (12 years and older) severe asthma patients with type 2 inflammation characterized by increased blood eosinophils and/or raised exhaled nitric oxide measured by FeNO test and inadequately controlled by inhaled high dose corticosteroids plus another asthma medicinal product.

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