Posted by Michael Wonder on 04 Jan 2024
Applied Therapeutics announces MAA validation and NDA submission of govorestat (AT-007) for treatment of classic galactosaemia
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term clinical outcomes benefit across a range of functional measures and favourable safety profile.
Applied Therapeutics today announced it has submitted a new drug application to the US FDA for govorestat (AT-007) for the treatment of classic galactosaemia.
