Sanofi - Aventis Groupe (SNYNF,SNY) announced the FDA has accepted, for review, the supplemental Biologics License Application for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria that is not adequately controlled with the current standard of care. The target action date for the FDA decision is October 22, 2023. The sBLA is supported by data from two Phase 3 trials, evaluating Dupixent in two different patient populations with uncontrolled CSU.
Dupilumab is being jointly developed by Regeneron and Sanofi. The companies are also studying Dupixent in chronic inducible urticaria triggered by cold in an ongoing Phase 3 trial.
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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.