FDA nod for first treatment for chronic rhinosinusitis with nasal polyps

The US Food and Drug Administration yesterday approved the first biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), and thus marking a third approved indication for Dupixent (dupilumab), a drug developed by US biotech Regeneron Pharmaceutical (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN).

“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” said Dr Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” she noted.

Dr George Yancopoulos, president and chief scientific officer at Regeneron, noted:“Importantly, many patients with CRSwNP also suffer from asthma, and Dupixent was shown to improve lung function in these patients as well. This approval further reinforces that IL-4 and IL-13 are key drivers of type 2 inflammation, and we continue to study Dupixent in other type 2 inflammatory diseases, including eosinophilic esophagitis, and food and environmental allergies.”