Dupixent Secures Third Indication with FDA Approval for Chronic Rhinosinusitis with Nasal Polyposis

Today, the FDA announced the approval of an expanded indication for Dupixent (dupilumab), a blockbuster drug jointly developed by Sanofi and Regeneron, for use in combination with other medications to treat adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the first biologic therapy approved by the FDA for patients with CRSwNP whose symptoms are not adequately controlled. Dupixent is currently approved for three indications driven by type 2 inflammation, including moderate-to-severe eczema, moderate-to-severe asthma, and CRSwNP.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic type 2 allergic inflammatory condition that leads to the growth of nasal polyps, obstructing the sinuses and nasal cavity, and causing severe symptoms such as nasal congestion, rhinorrhea, facial pain, and impaired sense of smell and taste. Long-term suffering from CRSwNP significantly impacts patients' health and normal daily life. To date, treatment options for patients remain very limited, typically requiring the use of intranasal and oral corticosteroids, or even surgery; however, recurrence rates are extremely high. Therefore, there is an urgent need for a safe, novel therapy to help them restore their quality of life.

Dupixent is a fully human monoclonal antibody that inhibits the IL-4 and IL-13 signaling pathways. These two proteins play a pivotal role in type 2 inflammation. Clinical trial data for Dupixent demonstrate that inhibition of IL-4 and IL-13 reduces type 2 inflammation, exerting significant therapeutic effects in chronic rhinosinusitis with nasal polyps (CRSwNP), asthma, and eczema.

The FDA approval was based on the results of two pivotal clinical trials (SINUS-24 and SINUS-52). In these trials, Dupixent met all primary and secondary endpoints. After 24 weeks of treatment, patients showed significant improvements in multiple measures, including:

In patients treated with Dupixent in combination with corticosteroid nasal sprays, the severity of nasal congestion/nasal obstruction was reduced by 57% (SINUS-24) and 51% (SINUS-52), respectively. In contrast, the control group receiving standard care alone showed reductions of only 19% and 15%. The nasal polyp score in patients treated with Dupixent decreased by 33% and 27%, respectively, whereas it increased by 7% and 4% in the control group.

Meanwhile, compared with the control group, Dupixent treatment significantly reduced patients’ need for systemic corticosteroids and surgery.

“Dupixent not only reduces nasal polyps but also improves associated symptoms of chronic rhinosinusitis. Nearly three-quarters of patients no longer require corticosteroids or surgical intervention after treatment with Dupixent,” said Dr. George D. Yancopoulos, President and Chief Scientific Officer at Regeneron. “Importantly, many patients with CRSwNP also suffer from asthma, and Dupixent can simultaneously improve lung function in these patients. This approval further demonstrates that IL-4 and IL-13 are key drivers of type 2 inflammation. We will continue to evaluate the efficacy of Dupixent in other type 2 inflammatory diseases, including eosinophilic esophagitis and food/environmental allergies.”

References:

[1] FDA approves Dupixent® (dupilumab) for chronic rhinosinusitis with nasal polyposis. Retrieved June 26, 2019, from https://www.prnewswire.com/news-releases/fda-approves-dupixent-dupilumab-for-chronic-rhinosinusitis-with-nasal-polyposis-300875539.html

Original Title: Flash | FDA Approves First Biologic Therapy for Sinusitis Today, Dupixent Secures Third Indication

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