Dupixent Wins Approval to Treat Chronic Rhinosinusitis with Nasal Polyposis
Sanofi and Regeneron’s Dupixent won another approval from the U.S. Food and Drug Administration (FDA) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). The approval marks the first biologic medicine for adults with CRSwNP in the United States.
The FDA approved Dupixent, an inhibitor of interleukin-4 (IL-4) and interleukin-13 (IL-13) which are key drivers in type 2 inflammation, for this indication after clinical data showed the medication reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids. Dupixent significantly improved key disease measures and met all primary and secondary endpoints in two Phase III trials. At 24 weeks, patients treated with Dupixent achieved statistically significant improvements in all primary and secondary endpoints, including 57% and 51% improvement in their nasal congestion/obstruction severity compared to a 19% and 15% improvement with placebo.
Additionally, 59% of clinical trial patients also had asthma, and those who were treated with Dupixent also experienced improvements in their lung function, the companies said. CRSwNP often occurs in combination with severe asthma. In the 59% of patients who also had asthma, the improvements in lung function were similar to patients in the Dupixent asthma program.
CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure. CRSwNP can be debilitating, with many patients opting for systemic steroids or nasal surgery, which often cannot control this disease. Many patients with CRSwNP have other type 2 inflammatory diseases like asthma, which is typically more severe asthma and more difficult to treat.
The latest approval means Dupixent has been approved for three conditions with underlying type 2 inflammation: moderate-to-severe atopic dermatitis, moderate-to-severe asthma and CRSwNP. The FDA approved Dupixent for this indication under Priority Review.
“Dupixent is the only approved therapy that has been 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,” George D. Yancopoulos, president and chief scientific officer at Regeneron said in a statement.
Yancopoulos said the approval of Dupixent for this indication further reinforces that “IL-4 and IL-13 are key drivers of type 2 inflammation.” Regeneron and Sanofi will continue to study Dupixent in other type 2 inflammatory diseases, including eosinophilic esophagitis, and food and environmental allergies, Yancopoulos said.
John Reed, Sanofi’s head of research and development, noted that in two Phase III trials, Dupixent helped patients significantly reduce their nasal congestion, and many patients experienced significant improvement in their sense of smell in four weeks.
In March, Dupixent was approved for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The FDA evaluated the Dupixent application under Priority Review. Dupixent won approval for this indication based off clinical trial data that showed average improvement in the Eczema Area and Severity Index (EASI) from baseline of approximately 66 percent. That was compared to 24 percent for placebo. Trial data also showed that more than 10 times as many patients had clear or almost clear skin with Dupixent compared to placebo.