Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat For Classic Galactosemia
Applied Therapeutics Receives Complete Response Letter From U.S. FDA Regarding New Drug Application For Govorestat For Classic Galactosemia
Applied Therapeutics, Inc. (NASDAQ:APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Galactosemia.
纳斯达克上市的applied therapeutics公司，一家专注于为罕见疾病创造变革性治疗方案的生物制药公司，今日宣布，美国食品药品监督管理局（FDA）已针对golovarestat的新药申请（NDA）发出完整答复函（CRL），以用于经典半乳糖血症的中枢神经系统可渗透的醛糖还原酶抑制剂（ARI）治疗。
The CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.
CRL指出，FDA完成了对申请的审查，并确定无法以目前的形式批准NDA，原因是临床申请方面存在不足。
Applied Therapeutics is reviewing the feedback from the FDA and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision along with appropriate next steps.
applied therapeutics正在审查FDA的反馈，并计划立即请求会议，讨论潜在重新提交NDA或上诉决定的要求，以及适当的下一步措施。
