Applied Therapeutics (APLT) said late Wednesday that the US Food and Drug Administration issued a complete response letter indicating the health regulator's decision not to approve the new drug application for govorestat to treat classic galactosemia due to "deficiencies in the clinical application."
The drugmaker said it is reviewing the regulator's feedback and plans to request a meeting to discuss requirements for a potential NDA resubmission or appeal.
Govorestat is also being developed to treat sorbitol dehydrogenase deficiency, the company said, adding it plans to file an NDA for that indication in Q1 2025.
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