NeuroVive receives Orphan Drug Designation in Europe for moderate and severe traumatic brain injury

13-Oct-2010 - Sweden

The European Commission has granted Orphan Medicinal Product Designation status to NeuroVive Pharmaceutical AB's product NeuroSTAT® for the treatment of patients with moderate and severe traumatic brain injury. This follows the positive opinion of the European Medicines Agency EMA in July. Orphan Drug Designation gives NeuroVive access to regulatory assistance from the European Medicines Agency (EMA) during the development phase, reduced regulatory fees, and market exclusivity in the EU for ten years after the product attains marketing authorization.

CEO Mikael Brönnegård comments: "The Commission's decision is an affirmation of our development strategy. From a market point of view, the possibility of ten years exclusivity from registration in the EU is extremely important to NeuroSTAT's continued development in neuroprotection and it creates the conditions for more rapid commercialization. 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."

Traumatic brain injury (TBI) is the leading cause of death in men between the ages of 15 and 45 and it disables almost 100,000 men and women in Europe each year. Victims of TBI often cannot return to work or independent living. There is no approved drug that can reduce brain damage that results from TBI. Cyclosporine, the active ingredient in NeuroVive's product NeuroSTAT®, has been shown to dramatically reduce brain damage from TBI in numerous animal studies.

CSO Eskil Elmér states: "An effective treatment for traumatic brain injury has long been sought by neurosurgeons. NeuroSTAT® cyclosporine has been shown to protect energy-producing mitochondria and counteract brain damage in TBI models. Our clinical development program will begin to test its efficacy in patients."

https://www.bionity.com/en/news/124318/neurovive-receives-orphan-drug-designation-in-europe-for-moderate-and-severe-traumatic-brain-injury.html