Sanofi and Regeneron’s Dupixent Gains Third Indication Approval in China for Moderate-to-Severe Atopic Dermatitis in Children Aged 6 to <12

On February 24, the official website of the National Medical Products Administration (NMPA) announced that the third indication for Sanofi/Regeneron's Dupixent (Dupilumab) has been approved for marketing in China. It is indicated for the treatment of pediatric patients aged ≥6 to <12 years and adult patients with moderate-to-severe atopic dermatitis who are not adequately controlled by topical prescription therapies or for whom topical prescription therapies are not advisable.

Dupilumab, jointly developed by Sanofi and Regeneron, is an anti-IL-4/IL-13 monoclonal antibody that selectively inhibits the key signaling pathways IL-4 and IL-13, blocks the Th2 inflammatory pathway, reduces the pathological response of Th2 inflammation, thereby treating diseases related to Th2 inflammation.

Dupilumab was the first biologic approved in the United States for the treatment of atopic dermatitis. It received its first FDA approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults. Since then, Sanofi has continued to expand the approved age range for dupilumab, gaining approvals in March 2019 for adolescents aged 12-17 years and in May 2020 for children aged 6-11 years with moderate-to-severe atopic dermatitis.

In June 2020, Dupilumab was approved for marketing in China for the first time 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's marketing application for treating moderate-to-severe atopic dermatitis in patients aged 12 years and above was approved; In June 2021, Dupilumab’s marketing application for treating moderate-to-severe atopic dermatitis in children aged ≥6 years to <12 years and adults was granted priority review by the CDE and has been recently approved.

According to the NextPharma database by PharmaBlock, dupilumab has been approved overseas for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. Several pivotal Phase III and registrational clinical trials are ongoing, including those for treating pediatric patients aged 6 months to 5 years with atopic dermatitis, prurigo nodularis, eosinophilic esophagitis, and chronic spontaneous urticaria.

Indications for which Dupixent has been approved or is under development

Dupilumab is currently Sanofi's flagship product, with sales reaching 5.249 billion euros in 2021, a year-on-year increase of 52.7%. This growth was driven by the continued demand from adult, adolescent, and 6-11-year-old pediatric patients with atopic dermatitis, as well as the label expansion and patient penetration in indications such as asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The drug is the first biologic in the United States to span across dermatology, allergy, and respiratory departments. Sanofi plans to develop it into a blockbuster with annual sales exceeding 10 billion euros.

However, on February 18 this year, Sanofi/Regeneron announced that the Phase III CUPID STUDY B of dupilumab for the treatment of omalizumab (Xolair)-refractory chronic spontaneous urticaria (CSU) patients did not meet its primary endpoint and was terminated based on a pre-specified interim analysis. Although positive numerical trends were observed in reducing itching and urticaria, the results of the interim analysis showed no statistical significance in the primary endpoint.