Applied Therapeutics announces MAA validation, NDA submission for AT-007

Applied Therapeutics announced it has submitted a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for govorestat, AT-007 for the treatment of Classic Galactosemia. The NDA was submitted in December 2023. In addition, the Company submitted a Marketing Authorization Application, MAA, to the European Medicines Agency, EMA, in the fourth quarter of 2023, which was subsequently validated and accepted for review in December 2023. “The submissions of both the NDA and MAA for govorestat are supported by rapid and sustained reduction in galactitol, which resulted in a meaningful benefit on clinical outcomes across pediatric patients, alongside a favorable safety profile,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “We look forward to working closely with both regulatory agencies throughout the review process and hope to bring the first treatment to patients with Galactosemia soon.”