Tuesday, April 16, 2024

Chronic Spontaneous Urticaria Treatment Dupixent® Approved in Japan

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Japan has emerged as a pioneer in the global healthcare landscape by granting the first-ever approval for Dupixent® (dupilumab) to treat chronic spontaneous urticaria (CSU) in individuals aged 12 and older whose condition remains uncontrolled with existing therapies. This milestone underscores Japan’s commitment to addressing the needs of patients with challenging and persistent skin conditions.

Dupixent’s approval by the Ministry of Health, Labor and Welfare (MHLW) marks its fifth indication in Japan and sixth globally, showcasing its potential as a transformative treatment option across a spectrum of diseases driven by type 2 inflammation.

CSU is identified as a chronic inflammatory skin disorder, characterized by spontaneous, debilitating hives and a persistent itch. This condition, believed to be partly driven by type 2 inflammation, often fails to be adequately managed by traditional treatments such as histamine (H1) antihistamines, leaving a significant patient population with limited alternatives and compromised quality of life. In Japan alone, approximately 110,000 individuals aged 12 years and older suffer from uncontrolled moderate-to-severe chronic spontaneous urticaria, highlighting a substantial unmet medical need within this demographic.

Dupixent Success in A Trial in Chronic Spontaneous Urticaria Treatment Leads to Approval in Japan

The approval of Dupixent in Japan was significantly influenced by the results from Study A of the LIBERTY-CUPID clinical trial program. This pivotal study evaluated Dupixent as an adjunctive therapy to standard-of-care H1 antihistamines in 138 CSU patients who remained symptomatic despite antihistamine use and had not received prior treatment with omalizumab.

The trial successfully met its primary and all key secondary endpoints, demonstrating that patients administered Dupixent in addition to antihistamines experienced marked reductions in itch severity over 24 weeks compared to those treated with antihistamines alone. Furthermore, the safety profile of Dupixent in treating chronic spontaneous urticaria was found to be generally consistent with its established safety profile in other dermatological indications.

Dupixent, a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), has revolutionized the understanding and treatment of diseases characterized by type 2 inflammation. The development program for Dupixent has underscored the significant role IL-4 and IL-13 play as central drivers of type 2 inflammation across a range of diseases.

Chronic Spontaneous Urticaria

Expanding Horizons in Chronic Inflammatory Conditions

Currently, Dupixent has been approved in various countries for several conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, eosinophilic esophagitis (EoE), and now chronic spontaneous urticaria, benefiting over 800,000 patients worldwide. The exploration of Dupixent’s efficacy in chronic spontaneous urticaria and other conditions continues, with ongoing clinical trials in numerous countries. Its development is part of a collaborative effort between Sanofi and Regeneron, which has spanned over 60 clinical trials involving more than 10,000 participants across various chronic diseases driven by type 2 inflammation.

Beyond the already approved indications, Dupixent is being investigated for potential applications in diseases like chronic pruritus of unknown origin, chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation, and bullous pemphigoid. These investigations aim to further expand the therapeutic impact of Dupixent, although the safety and efficacy for these additional uses have not yet been fully validated by regulatory authorities outside of Japan.

This approval not only represents a significant advancement in the treatment of CSU but also reaffirms the global healthcare community’s ongoing commitment to developing and making available innovative therapies for patients grappling with complex inflammatory conditions. As Dupixent becomes available for CSU in Japan, it offers hope for improved management and quality of life for thousands of patients facing the daily challenges of this persistent skin condition.


Resource: Sanofi, February 16, 2024

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