Sanofi's Dupilumab Receives NMPA Approval in China for Adolescents and Adults Aged 12+ with Moderate-to-Severe Atopic Dermatitis

According to the latest public notice from China's National Medical Products Administration (NMPA), the marketing application for a new indication of Sanofi’s dupilumab injection (English trade name: Dupixent) submitted in China has been officially approved. According to the priority review public notice from the NMPA Center for Drug Evaluation (CDE), this indication is for adolescent and adult patients aged 12 years and older with moderate-to-severe atopic dermatitis whose symptoms are inadequately controlled with topical prescription therapies, or for whom topical prescription therapies are not advisable.

Source: NMPA Official Website

Dupilumab, co-developed by Sanofi and Regeneron, is a monoclonal antibody that simultaneously inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13), and is the first targeted biologic approved globally by the U.S. FDA and the European EMA for the treatment of moderate-to-severe atopic dermatitis.

In March 2017, dupilumab was approved by the FDA as the first targeted biologic agent for the treatment of moderate-to-severe atopic dermatitis in adults, marketed under the brand name Dupixent®. Subsequently, Dupixent has received approvals for the indications of asthma and nasal polyps.

In China, dupilumab was approved in June 2020 for the treatment of moderate-to-severe atopic dermatitis in adults and has been included in the 2020 edition of China's National Reimbursement Drug List. Subsequently, Sanofi submitted two marketing authorization applications for new indications of dupilumab in China, targeting adolescents aged 12 years and older and adults with moderate-to-severe atopic dermatitis, and children aged 6 years and older but under 12 years and adults with moderate-to-severe atopic dermatitis, respectively. Both applications were included in the priority review and approval process on the grounds of pediatric use.

Executive Editor: Liuli

Disclaimer: This article is compiled content from Yaozhi.com. The copyright belongs to the original authors. It is intended solely to convey additional information and does not represent the views of this platform. Should you have any concerns regarding the content, copyright, or other related matters, please contact us by leaving a message on this website, and we will promptly delete the content.