Benzinga | Jun 17, 2021 07:01AM EDT

Applied Therapeutics Granted Fast Track Designation by FDA for AT-007 for Galactosemia

Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AT-007 for the treatment of Galactosemia, a rare metabolic disease. AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders, including Galactosemia, SORD and PMM2-CDG.

Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met. Applied Therapeutics plans to submit an NDA for Accelerated Approval of AT-007 for the treatment of Galactosemia in the third quarter of this year. FDA has previously granted Orphan Drug Designation and Pediatric Rare Disease status to AT-007 for Galactosemia.

"Galactosemia is a devastating rare metabolic disease that progressively worsens over time and greatly impacts patient quality of life," said Shoshana Shendelman PhD, Founder and CEO of Applied Therapeutics. "There are currently no drugs approved for Galactosemia, and we believe AT-007 has the potential to be the first drug approved for patients urgently in need of treatment. Fast Track Designation offers several important opportunities to work closely with the FDA through the review and approval process to ensure that AT-007 is available to patients as quickly as possible."