EC backs traumatic brain injury drugRSS Feed

A treatment for traumatic brain injury patients has been given Orphan Drug Designation by the European Commission (EC).

The status means NeuroVive Pharmaceutical's AB's NeuroSTAT product for the treatment of brain injury will receive regulatory support from the European Medicines Agency and will have market exclusivity in the EU for ten years after going on sale.

Mikael Bronnegard, the firm's chief executive officer, said gaining market exclusivity makes a huge difference to the development of the treatment.

"Orphan Drug Designation gives us access to important regulatory assistance which will greatly facilitate the development of neuroprotective therapy for acute treatment of patients with moderate and severe traumatic brain injury," he noted.

The product, the company claims, helps to protect energy-producing mitochondria and counteract damage to the brain.

Studies from the US have revealed the growing problem of soldiers returning from Afghanistan suffering from traumatic brain injuries caused by improvised explosive devices such as roadside bombs.

News brought to you by Serious Law specialists in brain injury

Posted by John Sherrington
 

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