Sanofi's Dupilumab Gains NMPA Approval in China for Adult Prurigo Nodularis

On September 22, the official website of the National Medical Products Administration (NMPA) showed that Sanofi's Dupixent (Dupilumab) has been approved for a new indication to treat adult patients with prurigo nodularis. This is the second indication for Dupixent approved in China.

Dupilumab, jointly developed by Sanofi and Regeneron, is an anti-IL-4/IL-13 monoclonal antibody that selectively inhibits key signals mediated by IL-4/IL-13, blocks the Th2 inflammatory pathway, reduces pathological responses of Th2 inflammation, thereby treating diseases associated with Th2 inflammation.

On March 28, 2017, Dupilumab received its first FDA approval for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). Additionally, Dupilumab consecutively gained four autoimmune indications between 2018 and 2022, including asthma, eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps (CRSwNP), and prurigo nodularis (PN).

In June 2020, Dupilumab was approved for the first time in China 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 expanded its patient population in China to include patients aged 12 years and above with moderate-to-severe atopic dermatitis; On February 14, 2022, Dupilumab once again extended its applicable population in China to include children aged 6 to 11 years with moderate-to-severe atopic dermatitis.

On March 23, 2023, Regeneron/Sanofi jointly announced the success of the pivotal Phase III BOREAS study of Dupilumab for the treatment of chronic obstructive pulmonary disease (COPD). This also marks Dupixent (Dupilumab) as the first biologic to significantly improve lung function in patients with COPD.

As the number of approved indications for dupilumab continues to increase along with sustained market penetration, the drug is set to become the world's second best-selling anti-inflammatory medication after AbbVie's Humira. Sanofi believes its future peak sales will exceed 13 billion euros. This figure does not include the potential to further boost sales targets in the chronic obstructive pulmonary disease (COPD) indication.

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