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Japan Approves Dupixent for Chronic Spontaneous Urticaria (CSU) Becoming First in the World to Do So

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This makes CSU treatment the sixth approved use globally.

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The Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU), according to today’s Regeneron and Sanofi press release.

CSU is characterized by recurrent and itchy hives often triggered by temperature or pressure on the skin. Both adults and children can be affected but it is twice as common in adult females. It is associated with immune disorders like food allergies and hypothyroidism.

About 110,000 people in Japan aged 12 years and older currently suffer from uncontrolled moderate to severe CSU. In the United States, 1% of the population is affected at any given time.

Dupixent is also used to treat atopic dermatitis and asthma with 800,000 being treated globally.

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