NeuroVive Pharmaceutical AB announced that the company’s candidate drug NeuroSTAT for treatment of moderate to severe traumatic brain injury (TBI) has received Fast Track designation from the US FDA.
NeuroSTAT protects and stabilises mitochondria. It focuses on secondary brain cell damage that occurs after head trauma.
The candidate drug has previously been evaluated in a European clinical phase II trial focused on safety, where analyses of brain cell injury biomarkers showed signals of clinical effect. In addition, in a clinically relevant experimental model, NeuroSTAT reduced the volume of brain injury by 35%. The drug has orphan drug designation in both Europe and the US.
TBI is caused by an external force to the head resulting in immediate damage to nerve cells. The damage continues to worsen for several days after the acute trauma. The most common causes for TBI are trips and falls, traffic accidents and assault and battery.
With more than 50 million new cases occurring each year, TBI is estimated to cost the global economy nearly 400 billion dollars annually in direct and indirect healthcare costs. A large number of patients suffer moderate to severe functional disabilities requiring intensive care and various forms of lifelong support.
Fast track designation makes the possibility to have its New Drug Application reviewed within a shorter timeframe. FT designated drugs address unmet medical needs in serious conditions, and the process is designed to facilitate accelerated drug development.