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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