Posted by Michael Wonder on 07 Mar 2023
Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria in adults and adolescents accepted for FDA review
7 March 2023 - The US FDA has accepted, for review, the supplemental biologics license application for Dupixent (dupilumab) 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, H1 antihistamine treatment.
The target action date for the FDA decision is 22 October 2023.
