Dupilumab Injection Submitted for Priority Review in China for the Treatment of Adult Prurigo Nodularis

On February 22, the CDE website showed that Sanofi's dupilumab injection is proposed to be included in the priority review for the treatment of adult prurigo nodularis.

Dupilumab, jointly developed by Sanofi and Regeneron, is an anti-IL-4/IL-13 monoclonal antibody that selectively inhibits key signals mediated by IL-4/IL-13, blocks the Th2 inflammatory pathway, reduces pathological responses of Th2 inflammation, thereby treating diseases associated with Th2 inflammation.

Dupilumab is the first biologic agent that spans across dermatology, respiratory medicine, and allergic reaction treatment. Its currently approved indications include atopic dermatitis, asthma, prurigo nodularis, eosinophilic esophagitis (for patients aged 12 years and above), and chronic rhinosinusitis with nasal polyps (CRSwNP), among others.

In June 2020, Dupilumab was approved for the first time in China to treat adult patients with moderate-to-severe atopic dermatitis who are not adequately controlled by topical prescription drugs or for whom the use of topical prescription drugs is not recommended. In September 2021, Dupilumab expanded its eligible population in China to include patients aged 12 years and above with moderate-to-severe atopic dermatitis. On February 14, 2022, Dupilumab further extended its indication in China to cover children aged 6-11 years with moderate-to-severe atopic dermatitis.

Dupixent, Sanofi's flagship product, generated revenue of 8.293 billion euros in 2022, representing a year-on-year increase of 43.8%, and became the main driver of annual revenue growth. Sanofi expects Dupixent’s sales to exceed 10 billion euros in 2023, making it a super blockbuster drug.

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