Avlayah (tividenofusp alfa-eknm)

BL 761485

Avlayah (tividenofusp alfa-eknm)

BL 761485

U.S. License Holder:

Denali Therapeutics Inc.

Date of License:

March-24-2026

Last Update:

Mar-31-2026

approved_indications FDA-Approved Indications

AVLAYAH (tividenofusp alfa-eknm) is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.

Methodology

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