Sanofi Submits BLA for Dupilumab (Dupixent®) in China for Moderate-to-Severe Atopic Dermatitis

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On December 25, the Center for Drug Evaluation (CDE) accepted Sanofi’s marketing application for dupilumab injection (Acceptance No.: JXSS1900067). Dupilumab is a human monoclonal antibody that was approved by the U.S. Food and Drug Administration (FDA) in March 2017 as the first targeted biologic agent for the treatment of moderate-to-severe atopic dermatitis in adults.

Dupilumab（Dupixent^®) By binding to IL-4Rα, it simultaneously blocks the IL-4 and IL-13 signaling pathways; IL-4 and IL-13 are considered the main drivers of persistent inflammation in atopic dermatitis.

March 28, 2017, Dupixent^®Approved by the FDA for market launch, it became the first biologic agent for treating moderate-to-severe atopic dermatitis, achieving sales of $247 million in its first year on the market. Subsequently, Dupixent received approvals for asthma and nasal polyps indications, reaching sales of $873 million in 2018.

Atopic dermatitis is a common, recurrent, chronic inflammatory skin disease. Patients typically present with chronic rashes characterized by inflammation and pruritus. Patients with moderate-to-severe atopic dermatitis often have widespread erythematous rashes covering most of the body, causing intense and persistent pruritus, dry skin, crusting, and exudation. Therapeutic options are very limited.

Currently, there is limited data on patients with atopic dermatitis in China. Publicly available data indicate that the prevalence of atopic dermatitis among children was nearly 13% in 2016, and when adult patients are included, approximately 8% of the population has been diagnosed with atopic dermatitis. At present, therapeutic options for moderate-to-severe atopic dermatitis in China are very limited. Topical therapies, such as corticosteroids, have limited efficacy in patients with moderate-to-severe disease and are difficult to use long-term, while systemic treatments, including immunosuppressants or oral glucocorticoids, may lead to serious side effects.

A Phase III clinical trial demonstrated that biweekly Dupixent® injections significantly alleviate disease severity in adults with moderate-to-severe atopic dermatitis. The study showed that Dupixent^®In the treatment group, 80% of patients achieved a 50% improvement in the Eczema Area and Severity Index (EASI) score after 16 weeks, compared with 37% in the placebo group. The mean reduction in the Itch Numeric Rating Scale (NRS) score was 56.2% in the Dupixent® treatment group versus 28.6% in the placebo group (P < 0.0001).

The Insight Global New Drug Database shows that Dupixent is currently undergoing multiple clinical trials worldwide, including Phase 3 trials for eosinophilic esophagitis, urticaria, and chronic obstructive pulmonary disease (COPD).

In China, the Phase 3 clinical trial of Dupilumab for adult patients with moderate-to-severe atopic dermatitis is ongoing (Clinical Trial Registration Number: CTR20181386), with a planned enrollment of 160 participants. In addition, international multicenter Phase 3 clinical trials for the treatment of chronic obstructive pulmonary disease (COPD) and asthma are also underway, with planned enrollments in China of 82 and 386 participants, respectively.

Currently, Dupixent has received regulatory approval and been launched in approximately 40 countries and regions, including the United States, Japan, and the European Union, benefiting around 65,000 patients. In February this year, Dupixent was introduced at the Dermatology Clinical Medical Center of Boao Super Hospital, where a patient with moderate-to-severe atopic dermatitis received the first injection. The patient experienced improvements in both the extent of skin lesions and the severity of pruritus, along with a significant enhancement in quality of life.

According to an EvaluatePharma report, Dupixent will become a key driver of Sanofi’s future growth. Although the drug’s sales amounted to only $247 million in 2017, it is projected to become the world’s second best-selling anti-inflammatory drug in 2024, after AbbVie’s Humira, with sales reaching $8.058 billion, driven by continuous expansion of clinical indications and market reach.