Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the Biologics License Application, BLA, for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease. There are currently no approved treatments for CHAPLE, an ultra-rare and life-threatening hereditary immune disease driven by an overactivation of the complement system. Pozelimab is an investigational fully human monoclonal antibody designed to block the activity of complement factor C5, a protein involved in complement system activation. The target action date for the FDA decision is August 20, 2023.
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