Regeneron Pharmaceuticals and Sanofi got the approval from the FDA for Dupixent for certain combinations to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
In the press release by Regeneron, it was noted that CRSwNP can be a debilitating condition, with many patients opting for systemic steroids or nasal surgery, which often cannot control this disease. Moreover, CRSwNP often occurs in combination with severe asthma, the company said.
George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, said that Dupixent is the first FDA-approved medicine for adults with chronic rhinosinusitis with nasal polyposis, and the only approved therapy shown to shrink nasal polyp size and also improve the signs and symptoms of the associated chronic rhinosinusitis. He pointed out that about three-quarters of patients treated with Dupixent no longer required either corticosteroids or surgery, the current standards of care.
He further highlighted that 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,” he said.
John Reed, M.D., Ph.D., Head of Research and Development at Sanofi, said that chronic rhinosinusitis with nasal polyposis can be a debilitating condition. Reed explained that today’s standard of care includes intranasal and systemic corticosteroids and sinus surgery, often leaves patients with CRSwNP with recurring symptoms.
Describing the trials, he said that Dupixent helped patients significantly reduce their nasal congestion, and many patients experienced significant improvement in their sense of smell in as quickly as four weeks. Furthermore, he said that treatment with Dupixent also reduced the need for systemic steroids and surgery, and led to improvements in health-related quality of life.
“Importantly, these patients with co-morbid asthma now have a treatment that can help improve their breathing,” Reed said.