FDA delays decision on Applied Therapeutics’ rare metabolic disease drug

The FDA has pushed back its de­ci­sion date on Ap­plied Ther­a­peu­tics’ treat­ment for clas­sic galac­tosemia to the end of No­vem­ber, the biotech an­nounced Thurs­day.

The agency pre­vi­ous­ly set an Aug. 28 dead­line for the rare dis­ease drug, called gov­ore­stat, but the de­ci­sion will now come by Nov. 28. Ac­cord­ing to Ap­plied Ther­a­peu­tics, the FDA said it need­ed ad­di­tion­al time “to re­view sup­ple­men­tal analy­ses of pre­vi­ous­ly sub­mit­ted da­ta.”

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