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Japan Drug Approvals | 日本の医薬品承認 | ニュース | 日本のニュース速報 | 健康管理 | 2024 | iPharmaCenter

  1. Dupixent approved for chronic spontaneous urticaria

Japan became the first country to approve Dupixent for chronic spontaneous urticaria

Japan becomes the pioneer nation to greenlight Dupixent for treating chronic spontaneous urticaria (CSU). Endorsement primarily rooted in the findings from a Phase 3 study demonstrating Dupixent's substantial reduction in itch compared to a placebo. CSU marks the fifth endorsed use for Dupixent in Japan and the sixth globally.

The Ministry of Health, Labor and Welfare (MHLW) in Japan has officially authorized the marketing and production of Dupixent (dupilumab) to tackle chronic spontaneous urticaria (CSU) in individuals aged 12 years and above whose current treatments fail to adequately manage the condition.

CSU, a persistent inflammatory skin disorder fueled partly by type 2 inflammation, manifests in sudden and incapacitating hives accompanied by enduring itchiness. Typically managed with histamine (H1) antihistamines targeting H1 receptors to alleviate symptoms, CSU often defies control with such treatments, leaving numerous patients with few viable alternatives. These individuals endure debilitating symptoms that severely disrupt their daily lives.

In Japan alone, approximately 110,000 individuals aged 12 and above contend with moderate-to-severe CSU that remains unmanageable despite the limited treatment options currently available.

The approval in Japan is primarily grounded in data gleaned from Study A of the LIBERTY-CUPID clinical trial program, which assessed Dupixent as an adjunct therapy alongside standard-of-care H1 antihistamines versus antihistamines alone (placebo) in 138 CSU patients who continued to experience symptoms despite antihistamine use and had not previously received omalizumab treatment. This study successfully achieved its primary and all key secondary endpoints. Patients receiving Dupixent in addition to standard-of-care antihistamines reported a marked reduction in itch severity compared to those on standard-of-care alone over a 24-week period. The safety profile of Dupixent in treating CSU generally aligned with its established safety profile in its approved dermatological applications.

Beyond CSU, Dupixent holds approvals in Japan for specific patient populations with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.


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