NeuroSTAT FDA fast track designation : Swedish mitochondrial medicine company NeuroVive Pharmaceutical has secured Fast Track designation from the US Food and Drug Administration (FDA) for NeuroSTAT for the treatment of moderate to severe traumatic brain injury (TBI).
NeuroVive said that NeuroSTAT FDA fast track designation will enable the drug’s clinical development and a direction towards its launch in the market.
According to the Swedish mitochondrial medicine company, NeuroSTAT is designed to protect and stabilize mitochondria. The investigational drug focuses on secondary brain cell damage that results from head trauma.
Previously, NeuroVive was assessed in a European clinical Phase 2 trial focused on the drug’s safety. Analyses of brain cell injury biomarkers in the mid-stage trial demonstrated signals of clinical effect. Apart from that, NeuroSTAT, in a clinically relevant experimental model, brought down the volume of brain injury by a significant extent by 35%. NeuroSTAT has orphan drug designation in Europe as well as the US.
NeuroSTAT FDA fast track designation makes the drug eligible for more frequent meetings and written communication with the US regulator, continuous feedback on each section of its new drug application, and also the possibility to have its NDA looked into within a shorter timeframe.
Drugs are given fast track designation if they can address unmet medical needs in serious conditions. The regulatory status is designed to enable fast-tracked drug development and, eventually, to make the new drugs available to patients faster.
Commenting on NeuroSTAT FDA fast track designation, Erik Kinnman – NeuroVive CEO, said: “The Fast Track designation and the recently approved IND (Investigational New Drug) are tremendous successes for our candidate drug NeuroSTAT, and a significant external validation of its quality and potential to address a tremendous unmet medical need.
“This will strengthen our position in the field and give us an advantage in partnering discussions concerning our planned Phase II efficacy study.”