Japan Approves Dupilumab for Chronic Spontaneous Urticaria

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Regeneron Pharmaceuticals and Sanofi today announced that Japan has approved the biologic dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria (CSU), making it the first country in the world to do so.¹

Japan’s Ministry of Health, Labor and Welfare granted marketing and manufacturing authorization for dupilumab for the treatment of chronic CSU in patients aged 12 years and older whose disease is not adequately controlled with existing therapy, Regeneron reported.

Approximately 110,000 people aged 12 years and older are affected by uncontrolled moderate to severe CSU in Japan, according to the company.

Regeneron reports that the Japanese approval is based primarily on data from Study A of the LIBERTY-CUPID clinical trial program evaluating dupilumab 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 dupilumab 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 dupilumab in CSU was generally consistent with the known safety of dupilumab in its approved dermatological indications, according to the company.

In addition to CSU, dupilumab is approved in Japan in certain patients with atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

In the United States, dupilumab is approved by the US Food and Drug Administration (FDA) for the treatment of atopic dermatitis in patients 6 months of age and older and for the treatment of prurigo nodularis in patients older than 18.

Dupilumab is also approved for the treatment of asthma in patients older than 6 years, maintenance treatment of CRSwNP in adults, and the treatment of eosinophilic esophagitis in patients older than 1 year of age.²

Trials of dupilumab for the treatment of CSU are underway in the US as Regeneron seeks FDA approval for this application.³

In October 2023, Regeneron and Sanofi experienced a setback on the path to US approval when the FDA issued a complete response letter regarding the companies’ biologics license application for dupilumab in CSU, stating that additional efficacy data were required to support an approval. The FDA did not identify any issues with safety or manufacturing.⁴

Dupilumab has been studied in more than 60 clinical trials around the world, involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation, according to Regeneron.

Related Articles

FDA Reviewing Dupilumab for Chronic Spontaneous Urticaria

Dupilumab for Pediatric Patients with Severe AD: A Look at the Data 4 Years After Approval

Dupilumab With Topical Corticosteroids Alleviates Clinical Symptoms of Pediatric Atopic Dermatitis

FDA Updates Dupilumab Label With Hand, Foot Atopic Dermatitis Involvement

References

1. Regeneron. Japan First in the world to approve Dupixent (dupilumab) for chronic spontaneous urticaria (CSU). News release. February 16, 2024. Accessed February 16, 2024. https://investor.regeneron.com/news-releases/news-release-details/japan-first-world-approve-dupixentr-dupilumab-chronic
2. Regeneron. Dupixent (dupilumab) injection. Accessed February 16, 2049. https://www.dupixent.com/
3. Olmstead S. Dupilumab plus antihistamines beats antihistamines alone in treating CSU. Dermatology Times. January 29, 2024. Accessed February 16, 2024. https://www.dermatologytimes.com/view/dupilumab-plus-antihistamines-beats-antihistamines-alone-in-treating-csu
4. Media update: Sanofi and Regeneron provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria. News release. October 20, 2023. Accessed February 16, 2024. https://www.sanofi.com/en/media-room/press-releases/2023/2023-10-20-21-00-00-2764252