Saol Therapeutics resubmits NDA for SL1009

Privately held, clinical-stage US pharmaceutical company Saol Therapeutics today announced the resubmission of its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease.

The resubmission follows a Type A meeting in December and a Type C meeting in March, during which the FDA provided guidance recommending additional survival analyses to support the application. This guidance enabled Saol to proceed directly to resubmission without conducting an additional trial, an outcome Saol believes reflects the FDA’s commitment to working constructively with sponsors to identify viable regulatory paths for programs serving patients with serious unmet needs.