NeuroVive Obtains U.S. Orphan Drug Designation for Traumatic Brain Injury
NeuroVive Pharmaceutical AB (NVP) announced that the U.S. FDA Office of Orphan Products Development has granted an Orphan Drug Designation to the company's NeuroSTAT® (cyclosporine) product for the treatment of moderate to severe traumatic brain injury. The Orphan Drug Designation covers both open and closed moderate to severe traumatic brain injury and gives NeuroVive market exclusivity for NeuroSTAT® in the United States for seven years from the date of marketing approval.
CEO Michael Bronnegard comments: "The U.S. Orphan Drug Designation for NeuroSTAT® was granted for patients with both open and closed traumatic brain injury, which exceeded our 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. Obtaining Orphan status in the U.S. 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 United States."
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