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The EC approval is based on two pivotal Phase III trials (the 24-week SINUS-24 and 52-week SINUS-52) that evaluated Dupixent 300mg every two weeks plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids. In these trials, Dupixent significantly improved key disease measures and met all primary and secondary endpoints.
Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
“People living with severe CRSwNP, are often desperate to find new treatment options given that current standard treatments such as intermittent courses of systemic corticosteroids or sinonasal surgery are associated with disease recurrence,” said George D Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron. “Dupixent significantly improved the signs and symptoms of severe CRSwNP, and also eliminated the need for further surgery or corticosteroid use in approximately three-quarters of patients. Today’s approval provides patients in Europe with the first biologic treatment to address the type 2 inflammation that underlies most CRSwNP. This is the third type 2 disease in which Dupixent has been approved, and we continue to investigate Dupixent in a broad range of type 2 inflammatory diseases.”
CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to persistent breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure or pain..
“Many patients with CRSwNP have co-morbid asthma, and those patients tend to have more severe disease that is often more difficult to treat,” said John Reed, MD., PhD, Global Head of Research and Development at Sanofi. “These particular patients may have an increased risk of asthma attacks, high symptom burden and a substantial adverse impact on health-related quality of life. Nearly 60% of the patients in the CRSwNP trials had asthma, and the data showed Dupixent provided an additional benefit of improved lung function in these patients.”