NeuroVive Pharmaceutical AB (NVP) announces that the US 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 US 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 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 United States.”
FDA Orphan drug designation is intended to support the clinical development of drugs for diseases and conditions that affect fewer than 200,000 people in the United States. The company gives market exclusivity for seven years in the US from the date the product receives marketing approval. Orphan Drug Designation also provides access to regulatory support from the FDA throughout the development process. Designation does not imply that the product has demonstrated the efficacy, safety and quality required for drug approval in the US These criteria must be met in the clinical phase of development and receive approval from the FDA before a market authorization for the product is granted.
NeuroVive is a Swedish drug development company focused on cyclosporine-based cyclophilin D inhibitors for mitochondrial neuroprotection. The active ingredient in NeuroVive’s lead product NeuroSTAT, cyclosporine (cyclosporin-A), has been repurposed for neuroprotection after years of use in humans for immunosuppression in organ transplantation.