FDA Warns Applied Therapeutics Over Data Handling and Dosing Errors in Govorestat Trials

The FDA has issued a warning to Applied Therapeutics over significant issues in the clinical trials of their drug candidate, govorestat, aimed at treating galactosemia. This reprimand follows an inspection that revealed objectionable conditions, including the mishandling of electronic data by a third-party vendor and dosing errors wherein some patients received lesser doses than planned[1][2]. The FDA criticized Applied Therapeutics for insufficiently addressing these issues and not providing complete information on these dosing discrepancies, which hampered the agency's ability to accurately assess the study data[1]. In response, the company has expressed its intention to rectify the issues raised, planning to reply to the warning within 15 days and seeking to engage further with the FDA regarding possible resubmission of their application[1].