FDA approves Dupixent for chronic rhinosinusitis with nasal polyposis
pharmafile | June 27, 2019 | News story | Sales and Marketing | Dupixent, FDA, Sanofi, US, pharma, rhinosinusitis
Regeneron Pharmaceuticals and Sanofi have revealed that their dual IL-4 and IL-13 inhibitor Dupixent (dupilumab) has secured FDA approval in the US for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in uncontrolled instances of the disease in adults.
The drug secured approval on the back of data from two Phase 3 trials showing that Dupixent met all of its primary and secondary endpoints and “significantly improved” all key disease measures when used in combination with standard-of-care mometasone furoate nasal spray (MFNS). Specifically, the combo improved nasal congestion/obstruction severity by 57% and 51% across both trials, compared to 19% and 15% with placebo, and reduced nasal polyps scores by 33% and 27% compared to just 7% and 4% with placebo – meeting the primary endpoints of the studies.
For secondary endpoints, the Dupixent combo demonstrated an improvement of 42% and 27% in sinus opacification compared to 4% and 0% with placebo, while loss of smell was improved by 52% and 45% compared to 12% and 10% with placebo.
CRSwNP is a chronic condition which affects the upper airway, blocking the sinuses and nasal passages, leading to difficulty breathing, congestion, discharge, facial pressure, and reduced sense of smell and taste. The disease is also often co-morbid with other type 2 inflammatory diseases such as asthma, which can lead to an increased risk of asthma attacks, higher symptom burden. In the trial results submitted to the FDA, 59% of participants had 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. In fact, approximately three-quarters of patients treated with Dupixent no longer required either corticosteroids or surgery, the current standards of care,” remarked Dr George D Yancopoulos, President and Chief Scientific Officer at Regeneron. “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.”
Dr John Reed, Head of Research and Development at Sanofi, also commented: “Chronic rhinosinusitis with nasal polyposis can be a debilitating condition. Today’s standard of care – which includes intranasal and systemic corticosteroids and sinus surgery – often leaves patients with CRSwNP with recurring symptoms. In two Phase 3 trials, 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. 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.”
Matt Fellows
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