Posted by Michael Wonder on 28 Jan 2025
Saol Therapeutics announces FDA acceptance of new drug application for SL1009 for treatment of pyruvate dehydrogenase complex deficiency
28 January 2025 - Saol Therapeutics announced today that the US FDA has accepted for review the new drug application for SL1009, sodium dichloroacetate oral solution. The solution will be used with a proprietary genetic test to treat an orphan paediatric mitochondrial disease, pyruvate dehydrogenase complex deficiency.
The FDA granted priority review for the new drug application and has set a goal date of 27 May 2025.
