Regeneron and Sanofi have announced that the companies’ joint drug, Dupixent (dupilumab), has been approved for a new indication; severe chronic rhinosinusitis with nasal polyposis (CRSwNP).
The decision marks the first biologic approved in the European Union for the indication, and means that the treatment is now approved for three type II inflammatory diseases: severe CRSwNP, severe asthma and moderate-to-severe atopic dermatitis.
The European Commission states that the move was based on two pivotal Phase III trials (the 24-week SINUS-24 and 52-week SINUS-52) that evaluated Dupixent 300 mg every two weeks, plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.
In the trials, the fully-human monoclonal antibody significantly improved key disease measures and met all primary and secondary endpoints – leading to the extension.
Many patients with CRSwNP have “co-morbid asthma, and those patients tend to have more severe disease that is often more difficult to treat," explained John Reed, 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 percent 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."
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.