The U.S. Food and Drug Administration (FDA) has accepted Ionis New Drug Application (NDA) for zilganersen, the investigational treatment for Alexander Disease for Priority Review. The acceptance of the NDA is the critical first step in the FDA review process. The FDA will now begin a thorough review of the application. Priority Review designation is granted for medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition, with the expectation of the FDA taking action within six months, compared to 10 months under standard review. Previously, the FDA granted zilganersen Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations.
To read the full community statement: FDA Accepts New Drug Application for Zilganersen
