FDA ApprovedUnited States
New Weekly Infusion for Children with Hunter Syndrome
Avlayah (tividenofusp alfa-eknm) for neurologic Hunter syndrome (MPS II)
FDA accelerated approval (24 March 2026 letter; press 25 March 2026) for Avlayah (tividenofusp alfa-eknm) — a once-weekly IV enzyme replacement for neurologic…
Avlayah is a weekly infusion for the brain effects of Hunter syndrome in children of at least 5 kilograms.