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15-Mar-2019

FDA to undertake priority review of Dupixent® (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps

PARIS and TARRYTOWN, NY - March 8, 2019 - The  U.S. 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). 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. Persistent symptoms of CRSwNP have a substantial adverse impact on patients' health-related quality of life, which can be measured by a composite endpoint that includes reduced productivity and activities of daily living, inablility to enjoy food, lack of sleep and fatigue. People with co-morbid asthma and CRSwNP tend to have more severe disease and are often more difficult to treat.

 

The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP despite previous treatment with surgery and/or systemic corticosteroids. About 60% of patients in the trials had co-morbid asthma. Data from these trials were presented at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in February 2019. In addition to moderate-to-severe atopic dermatitis and moderate-to-severe asthma, this is the third type 2 allergic inflammatory disease in which Dupixent has demonstrated positive Phase 3 results.

 

Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation, which seem to underlie CRSwNP as well as several other allergic diseases.

 

In the U.S., Dupixent is approved for the treatment of adults  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 on 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. This indication remains investigational in the EU, pending the adoption of the CHMP opinion by the European Commission. Other potential uses for Dupixent, including in CRSwNP, are investigational and the safety and efficacy have not been evaluated by the U.S. Food and Drug Administration, the EMA or any other regulatory authority. Dupilumab is being developed jointly by Sanofi and Regeneron as part of a global collaboration agreement. 

 

Dupilumab development program

 

In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including chronic rhinosinusitis with nasal polyps (Phase 3 completed), adolescent (12 to 17 years of age) atopic dermatitis (Phase 3 completed), pediatric (6 to 11 years of age) atopic dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic dermatitis (Phase 2/3), pediatric (6 to 11 years of age) asthma (Phase 3), eosinophilic esophagitis (Phase 2/3), and food and environmental allergies (Phase 2). A future trial is planned for chronic obstructive pulmonary disease. Dupilumab is also being studied in combination with REGN3500, which targets IL-33. These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority.

 

For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.

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Last Updated: 19-Mar-2019