Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
Applied Therapeutics announces FDA extension of review period for govorestat NDA by three months, new PDUFA target action date set for November 28, 2024, for treatment of Classic Galactosemia. Govorestat, an investigational ARI, demonstrated rapid and sustained reduction in galactitol with favorable safety profile in Phase 3 studies. If approved, it would be the first medication for Galactosemia.
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Applied Therapeutics announces FDA extension of review period for govorestat NDA by three months, new PDUFA target action date set for November 28, 2024, for treatment of Classic Galactosemia. Govorestat, an investigational ARI, demonstrated rapid and sustained reduction in galactitol with favorable safety profile in Phase 3 studies. If approved, it would be the first medication for Galactosemia.