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FDA Approves Dupixent in the U.S. for Chronic Spontaneous Urticaria

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

By: Rachel Klemovitch

Assistant Editor

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. The US approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and a...

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