United States, March 31 -- The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II). Hunter syndrome is a rare inherited lysosomal disorder in which sugar molecules called glycosaminoglycans build up within the cells' lysosomes. This substrate accumulation affects physical and mental development by causing abnormalities in the skeleton, heart, respiratory system, brain, and other organs.Avlayah, an IV infusion given once weekly, is approved to treat neurologic manifestations of Hunter syndrome when the medication is started in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic i...