US clears Sanofi, Regeneron's Dupixent for chronic rhinosinusitis with nasal polyposis

Sanofi and Regeneron Pharmaceuticals announced Wednesday that the FDA has expanded the label for Dupixent (dupilumab) to include use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. George Yancopoulos, chief scientific officer at Regeneron, noted that "patients with CRSwNP also suffer from asthma, and Dupixent was shown to improve lung function in these patients as well." He added that this latest approval "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 expanded approval was supported by results from the pivotal SINUS-24 and SINUS-52 studies, part of the Phase III LIBERTY clinical development programme. The trials evaluated Dupixent every two weeks with standard-of-care mometasone furoate nasal spray, which Merck & Co. markets as Nasonex, compared to placebo plus mometasone furoate nasal spray in 724 adults with CRSwNP who were symptomatic despite taking intranasal corticosteroids. Data unveiled in February showed that Dupixent significantly reduced nasal polyp size and nasal congestion versus placebo, while those who took Dupixent also reported an increased ability to smell and required less nasal polyp surgery and oral steroids.

Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, stated that "Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids." The FDA awarded Dupixent priority review for CRSwNP in March.

Commenting on the approval, Cowen & Co. analyst Yaron Werber said the new indication is "a sizable, but overlooked market with few entrenched competitors." He estimated that the expanded label will boost global Dupixent sales by $956.3 million in 2024.

Dupixent was approved by the FDA in 2017 for use in certain adults with moderate-to-severe atopic dermatitis, and recently expanded to include adolescents aged 12 years to 17 years. The drug has also been cleared in the US as an add-on maintenance therapy for use in moderate-to-severe asthma in patients 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Sales of Dupixent more than tripled in the first quarter to €329 million ($374 million). 

For additional analysis, see Physician Views snap poll results - More data support threat of JAK inhibitors to Dupixent in atopic dermatitis, and Physician Views snap poll results - Dupixent satisfaction rates sky high, but demand for oral alternatives is real.

To read more Top Story articles, click here.