NeuroVive’s NeuroSTAT project receives FDA fast track designation

NeuroVive Pharmaceutical

27 July 2019 - NeuroVive Pharmaceutical today announced that the company’s candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received fast track designation from the US FDA, facilitating its clinical development and path forwards to market.

NeuroSTAT’s FDA Fast Track designation makes NeuroVive eligible, for example, for more frequent meetings and written communication with the FDA, continuous feedback on each section of its New Drug Application, NDA (for sale and marketing in the US), as well as the possibility to have its NDA reviewed within a shorter timeframe. Fast Track designated drugs address unmet medical needs in serious conditions, and the process is designed to facilitate accelerated drug development and, ultimately, to get new drugs to patients faster.

NeuroSTAT protects and stabilises mitochondria and is in development for treatment of moderate to severe traumatic brain injury. It focuses on secondary brain cell damage that occurs after a 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 significantly reduced the volume of brain injury by 35%. NeuroSTAT has orphan drug designation in both Europe and the US.

Read NeuroVive Pharmaceutical press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track