FDA Grants Priority Review to Dupixent for Treatment of Adults with Severe Chronic Rhinosinusitis

Dupixent (dupilumab) is already approved in the U.S. to treat moderate-to-severe atopic dermatitis and asthma.

Severe chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic disease of the upper airway that results mainly from type 2 inflammation and leads to the formation of polyps that obstruct the sinuses and nasal passages. The polyps can cause breathing difficulties, nasal discharge and facial pain/pressure. The condition can also often result in reduction or loss of sense of smell and taste. Currently, there are no FDA-approved biologic medicines to treat CRSwNP. Patients who also have asthma tend to have a more severe form of the disease and are more difficult to treat. They often experience recurrence despite previous treatment with surgery and/or systemic corticosteroids.

Dupixent (dupilumab), a drug from Regeneron Pharmaceuticals and Sanofi, was recently granted Priority Approval by the FDA as an add-on maintenance treatment for adults with inadequately controlled CRSwNP. The drug is used for the 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, and 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.

The supplemental Biologics License Application filed by the two companies for Dupixent in CRSwNP is based on the results of two phase III studies evaluating its efficacy and safety when combined with standard-of-care corticosteroid nasal spray in patients with recurring severe CRSwNP, approximately 60% of whom also had asthma. The human monoclonal antibody is designed to inhibit signaling of interleukin-4 and interleukin-13 (IL-4 and IL-13), two proteins that play key roles in type 2 inflammation.

Regeneron and Sanofi are also studying Dupixent in other diseases, including chronic rhinosinusitis with nasal polyps, adolescent and pediatric atopic dermatitis, pediatric asthma, eosinophilic esophagitis and food and environmental allergies. In addition, a trial will be conducted in for chronic obstructive pulmonary disease. Separately, Dupixent is being investigated in combination with REGN3500, which targets IL-33.

 

 

Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications