US FDA declines to approve Applied Therapeutics' genetic disease drug (updated)
27/11/2024 21:28
(Adds details on FDA letter and background in paragraphs 2-4)
Nov 27 (Reuters) - Applied Therapeutics APLT.O said on
Wednesday that the U.S. FDA declined to approve its drug to
treat galactosemia, a rare genetic metabolic disease, casting a
cloud over the company's hopes for its first commercial product.
The Food and Drug Administration's letter to the company
said the marketing application for the drug, govorestat, cannot
be approved in its current form, due to certain deficiencies.
The drug developer is reviewing the feedback from the FDA
and plans to immediately request a meeting to discuss
requirements for a potential resubmission of the application or
appeal of the decision.
The health regulator previously delayed its decision on
govorestat in March to review supplemental analyses submitted by
the company.
(Reporting by Sneha S K, Mariam Sunny and Christy Santhosh in
Bengaluru; Editing by Shailesh Kuber)
((Sneha.SK@thomsonreuters.com))