Tividenofusp alfa, marketed as Avlayah, is an enzyme replacement therapy used to treat the neurologic manifestations of Hunter syndrome, also called mucopolysaccharidosis type II, in presymptomatic or symptomatic children weighing at least five kilograms before advanced neurologic impairment develops. It is a hydrolytic lysosomal glycosaminoglycan-specific enzyme. Hunter syndrome is a rare inherited lysosomal disorder in which sugar molecules called glycosaminoglycans build up within cells' lysosomes, causing abnormalities of the skeleton, heart, respiratory system, brain and other organs, and affecting physical and mental development. The drug's prescribing label carries a boxed warning for potential allergic reactions including anaphylaxis, with common side effects including infections, fever, gastrointestinal symptoms and rash. It received United States FDA approval in March 2026.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountA: Alimentary Tract and Metabolism 2 Route of Administration First Approved / Isolated Year Sources
1. Tividenofusp alfa (Wikipedia)
Lead section, approval-status statementQuote, Lead section, approval-status statement
Tividenofusp alfa was approved for medical use in the United States in March 2026.
2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code AQuote, First-level anatomical group codes, Code A
Alimentary tract and metabolism
3. Tividenofusp alfa (Wikipedia)
WikipediaInfobox drug, routes_of_administrationQuote, Infobox drug, routes_of_administration
Intravenous
4. Tividenofusp alfa (Drugs@FDA BLA761485)
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