Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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Source: Yahoo! Finance
More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade Paris and Tarrytown, NY, November 15, 2024. The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025. The resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program ( Study A Study B , and Study C ) for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamin
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