Sanofi Submits New Indication Application for Dupilumab in China

Source: Medical Perspective

According to the latest public announcement by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, Sanofi has submitted a new indication marketing application for dupilumab injection in China, which was accepted on May 10. Publicly available information indicates that dupilumab is a monoclonal antibody that simultaneously inhibits IL-4 and IL-13, jointly developed by Sanofi and Regeneron. It is the first targeted biologic approved by the U.S. FDA and the European EMA for the treatment of moderate-to-severe atopic dermatitis worldwide. According to Sanofi’s financial reports, global sales of dupilumab exceeded €3.5 billion in 2020.

Screenshot source: CDE official website

Clinical studies of dupilumab have demonstrated that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key drivers of type 2 inflammation, which plays a major role in diseases such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). Dupilumab is a fully human monoclonal antibody that selectively inhibits the key signaling pathways of IL-4 and IL-13 through an innovative “dual-target” mechanism of action, thereby blocking the type 2 inflammatory pathway, reducing pathological responses associated with type 2 inflammation, and providing mechanistic treatment for type 2 inflammation-related diseases.

In China, dupilumab was included by the Center for Drug Evaluation (CDE) in the second batch of the List of Overseas New Drugs Urgently Needed for Clinical Use in 2019, and it was first approved in China in June 2020 for the treatment of moderate-to-severe atopic dermatitis in adults. According to reports, dupilumab demonstrates a favorable safety and tolerability profile, effectively improving patients’ quality of life while rapidly, significantly, and sustainably alleviating symptoms such as pruritus and skin lesions. Currently, dupilumab has been included in the 2020 edition of the National Reimbursement Drug List of China.

It is worth noting that, in addition to moderate-to-severe atopic dermatitis in adults, dupilumab also holds potential for the treatment of pediatric atopic dermatitis. In September 2020, Sanofi submitted a new indication application for dupilumab in China, which was included in the priority review program. According to the public information on priority review, the indication applied for last year was “for the treatment of moderate-to-severe atopic dermatitis in adolescents and adults aged 12 years and older whose disease is not adequately controlled with topical prescription therapies, or when such therapies are not advisable; it may be used with or without topical corticosteroids.”

Source: CDE Official Website

In addition to atopic dermatitis, Sanofi is also exploring the efficacy of dupilumab in treating other type 2 inflammatory diseases, including eosinophilic esophagitis, asthma, and sinusitis. The Chinese Drug Clinical Trial Registration and Information Publicity Platform shows that Sanofi is conducting a randomized, double-blind, international multicenter (including China) Phase 3 clinical trial to evaluate the efficacy and safety of dupilumab in patients with allergic fungal rhinosinusitis (AFRS).

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