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Avlayah

Tividenofusp Alfa-Eknm
Enzyme Replacement Therapy
Injection

Avlayah is a prescription intravenous therapy used to treat neurological manifestations of Hunter syndrome (MPS II), a rare genetic disorder caused by enzyme deficiency leading to harmful substrate accumulation.

Unlike traditional enzyme replacement therapies, Avlayah is designed to cross the blood–brain barrier, allowing delivery of the functional enzyme to both the body and the brain, helping reduce disease burden.

Hunter syndrome can lead to progressive neurological decline and impact overall development and quality of life. Targeted therapies like Avlayah aim to slow progression and improve patient outcomes.

Avlayah is administered through regular intravenous infusions under medical supervision as part of a long-term treatment approach.

Approval Date
24-Mar-26
Data Exclusivity Expiry
24-Mar-30
Market Exclusivity Expiry
24-Mar-38
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
11
2027
61
2028
130
2029
196
2030
265
2031
338
2032
410
Molecule profile

Details & specifications

Molecule
Tividenofusp Alfa-Eknm
Innovator
DENALI THERAPEUTICS INC
Dosage Form
Injection
Strength
150 mg/vial
Therapeutic Category
Enzyme Replacement Therapy
Usage
To treat certain individuals with Hunter syndrome (mucopolysaccharidosis type II or MPS II)
Good to know

Frequently asked questions

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