Applied Therapeutics, Inc. (APLT) said on Friday that the U.S. Food and Drug Administration or FDA has extended the review period of the New Drug Application or NDA for Govorestat, AT-007, to treat Classic Galactosemia by three months to November 28.
The FDA noted that it requires additional time to review the supplemental analyses of the previously submitted data as the additional information constitutes a major amendment to the previously filed NDA.
In February 2024, the company had 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.
Govorestat is an investigational, novel aldose reductase inhibitor or ARI being developed for the treatment of several rare diseases.
The NDA filing of govorestat is supported by rapid and sustained reduction in galactitol, which benefitted pediatric patients, with a favorable safety profile.
The submission package included clinical outcomes data from the Phase 3 registrational ACTION-Galactosemia Kids study in children aged 2 to17 with Galactosemia, the Phase 1/2 ACTION-Galactosemia study in adult patients with Galactosemia, and preclinical data.
If approved, govorestat would be the first medication for the treatment of Galactosemia and would be Applied Therapeutics' first commercial product.
APLT was down by 14.71 percent at $5.80 after close on Thursday on the Nasdaq.
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