On Feb. 16, 2024, Regeneron and Sanofi announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy.

Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch. CSU is typically treated with histamine-1 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.

The Japanese approval is based primarily on data from Study A of the LIBERTY-CUPID clinical trial program evaluating Dupixent as an add-on therapy to standard-of-care H1 antihistamines compared to antihistamines alone (placebo) in 138 patients with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab.

This study met the primary and all key secondary endpoints. Patients taking Dupixent added to standard-of-care antihistamines experienced a significant reduction in itch severity compared to standard of care alone at 24 weeks. The safety profile of Dupixent in CSU was generally consistent with the known safety of Dupixent in its approved dermatological indications.

Dupixent, which was invented using Regeneron’s proprietary VelocImmune^® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, CRSwNP, prurigo nodularis and eosinophilic esophagitis (EoE).