The FDA has approved Dupixent, the first biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
The approval, granted to Regeneron Pharmaceuticals and Sanofi, gives a new treatment option for patients many of which have had to opt for systemic steroids or nasal surgery, which often cannot control this disease. Moreover, CRSwNP often occurs in combination with severe asthma.
“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,” said George D. Yancopoulos, President and Chief Scientific Officer at Regeneron.
“In fact, approximately three-quarters of patients treated with Dupixent no longer required either corticosteroids or surgery, the current standards of care.
“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.”
The approval is based on two pivotal trials (the 24-week SINUS-24 and 52-week SINUS-52) that are part of the Phase 3 LIBERTY clinical trial program.
These trials evaluated Dupixent 300 mg every two weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared to placebo injection plus MFNS.
In these trials, Dupixent significantly improved key disease measures and met all primary and secondary endpoints.