Applied Therapeutics: FDA extends review period for NDA for govorestat

Applied Therapeutics announced that the U.S. FDA has extended the review period for the New Drug Application for govorestat (AT-007) for the treatment of Classic Galactosemia by three months. The FDA has set a new Prescription Drug User Fee Act target action date of November 28. The FDA notified Applied Therapeutics that it required additional time to review supplemental analyses of previously submitted data that had been provided by Applied in response to the FDA’s routine information requests and determined that the additional information constitutes a Major Amendment to the NDA. In February 2024, the company announced that the FDA accepted and granted Priority Review to the NDA. Govorestat was previously granted Pediatric Rare Disease designation, and will qualify for a Priority Review Voucher upon approval.