FDA Grants Orphan Drug Designation to Neuren Pharmaceuticals' NNZ-2591 for Newborn Brain Injury

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Neuren Pharmaceuticals' NNZ-2591 for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE), a severe brain injury affecting newborns. This designation provides incentives, including seven years of marketing exclusivity and a waiver of the prescription drug user fee, for drugs addressing rare diseases affecting fewer than 200,000 patients in the U.S.