FDA pumps brakes on Applied's govorestat, seeks more time for review

2024-03-28

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Applied Therapeutics said the FDA has extended its review timeline for govorestat (AT-007), a potential treatment for classic galactosemia, by three months. The agency is now expected to render its decision on the aldose reductase inhibitor by November 28. Company shares slipped about 14% on the news during after-hours trading Thursday.

According to Applied, the FDA said it needs more time to review supplemental analyses of previously submitted data that had been provided by the company. The agency determined that the additional information constitutes a major amendment to the application, which had been granted a priority review in February.

"While the PDUFA action date extension represents a delay, we remain confident in the potential for govorestat approval for galactosemia and we will continue to work closely with the FDA throughout the review process," stated CEO Shoshana Shendelman.

An application for govorestat was submitted to the US agency despite failing a Phase III paediatric study last year. At the time, Shendelman said the study had nevertheless demonstrated "compelling evidence" of clinical benefit. Regulators in Europe are also reviewing the treatment for galactosemia.

The extended FDA timeline comes on the heels of Applied's recent announcement of detailed data from the Phase III INSPIRE study evaluating govorestat as a treatment for sorbitol dehydrogenase (SORD) deficiency. Despite meeting two interim primary endpoints, the drug fell short of some key functional measurements.

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