Sanofi and Regeneron have received the European Commission (EC) approval for Dupixent (dupilumab) to treat adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP).
The approval allows the use of the drug alongside intranasal corticosteroids for patients who fail to experience disease control with systemic corticosteroids or surgery.
CRSwNP is a chronic respiratory condition that affects the upper airway, blocking the sinuses and nasal passages. The disease is associated with breathing difficulties, decrease or loss of sense of smell and taste and facial pressure or pain, as well as nasal congestion and discharge.
Dupixent is a fully human monoclonal antibody designed to inhibit the interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling. Sanofi is developing the drug in alliance with Regeneron Pharmaceuticals.
Previously, the EC approved the drug for the treatment of patients with severe asthma. Some moderate-to-severe atopic dermatitis patients also use Dupixent as a treatment.
Sanofi research and development global head John Reed said: “Many patients with CRSwNP have co-morbid asthma and those patients tend to have more severe disease that is often more difficult to treat.
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“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% 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.”
The EC approval for CRSwNP indication comes after the review of Phase III SINUS-24 and SINUS-52 clinical trials, conducted to assess 300mg Dupixent given every two weeks as add-on therapy with intranasal corticosteroids.
Both studies met all primary and secondary endpoints, where Dupixent led to significant improvements in principal disease measures compared to placebo and intranasal corticosteroids combination.
The drug improved nasal congestion / obstruction severity, sinus opacification and loss of smell, as well as decreased nasal polyps score.
Sanofi and Regeneron are also developing the drug in multiple type 2 inflammation-driven conditions such as eosinophilic esophagitis and chronic obstructive pulmonary disease.