Dupixent (Dupilumab) Receives NMPA Approval in China for Moderate-to-Severe Atopic Dermatitis

On June 19, 2020, information on pending collection of drug approval documents indicated that Sanofi’s blockbuster atopic dermatitis therapy, dupilumab (Dupixent), had been officially approved for marketing. On December 25, 2019, the Center for Drug Evaluation accepted the marketing application for dupilumab injection (acceptance number: JXSS1900067), which was subsequently included in the priority review program. The time from application submission to formal approval was less than six months.

The active pharmaceutical ingredient in Dupixent is dupilumab, a fully human monoclonal antibody that specifically inhibits the overactivated signaling of two key proteins, IL-4 and IL-13. IL-4 and IL-13 are inflammatory cytokines considered to be key drivers of the persistent underlying inflammation in atopic dermatitis.

In March 2017, Dupixent received approval from the U.S. FDA for adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled by topical prescription therapies or when these therapies are not advisable. This approval made Dupixent the first targeted biologic agent approved for the treatment of moderate-to-severe atopic dermatitis in adults.

Since its market launch, Dupixent’s sales have surged, reaching $247 million in the first year; $873 million in 2018; and $2.3 billion globally in 2019. In a 2018 report, EvaluatePharma projected the 2024 sales of innovative therapies for atopic dermatitis, with Dupixent topping the list at $5.1 billion, far ahead of second-place Pfizer’s Eucrisa at $900 million. In its 2019 financial report, Sanofi explicitly stated that it expects Dupixent’s peak annual sales to exceed €10 billion.

Currently, Dupixent has been approved for three indications: atopic dermatitis, moderate-to-severe asthma (in patients aged ≥12 years), and chronic rhinosinusitis with nasal polyps (in adults). Sanofi and Regeneron are also developing Dupixent for the treatment of diseases driven by allergies and other type 2 inflammatory responses, including pediatric asthma (Phase 3), pediatric atopic dermatitis (Phase 2/3), chronic obstructive pulmonary disease (COPD) (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2).

In late May this year, Regeneron and Sanofi announced positive results from Part A of a pivotal Phase 3 clinical trial of Dupixent in patients aged 12 years and older with eosinophilic esophagitis (EoE). The results demonstrated that the trial met its primary co-endpoints and all key secondary endpoints, making Dupixent the first and only biologic to show positive and clinically meaningful outcomes in this patient population.