Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)
- Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo
- CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally
Paris and Tarrytown, N.Y. February 16, 2024. 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 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. Approximately 110,000 people aged 12 years and older suffer from uncontrolled moderate-to-severe CSU in Japan, for which there are currently limited treatments.
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.
In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.
About Dupixent
Dupixent 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).
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and CSU in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Japan, Europe and the U.S. More than 800,000 patients are being treated with Dupixent globally.
The potential use of Dupixent in CSU is under clinical development in additional countries around the world, and its safety and efficacy have not been fully evaluated by any regulatory authority outside of Japan.
Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation, and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
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About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
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