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news.The US Food and Drug Administration Office of Orphan Products Development has granted an orphan drug designation (ODD) to the NeuroVive Pharmaceutical's NeuroSTAT (cyclosporine) product for the treatment of moderate to severe traumatic brain injury.
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The ODD covers both open and closed moderate to severe traumatic brain injury and gives NeuroVive Pharma market exclusivity for NeuroSTAT in the US for seven years from the date of marketing approval.
NeuroVive Pharma CEO Michael Bronnegard said the US ODD for NeuroSTAT was granted for patients with both open and closed traumatic brain injury, which exceeded their expectations.
"It indicates that there is indeed a significant medical need in this group of patients, where no effective pharmaceutical treatment is yet available to treat acute neurodegenerative injuries," Bronnegard said.
"Obtaining Orphan status in the US is an important milestone in our company’s efforts to develop an effective drug for acute brain injuries and this designation can facilitate more rapid development and commercialization in the US."