Denali Therapeutics receives FDA approval for AVLAYAH in Hunter syndrome

Denali Therapeutics Inc.

FDA grants accelerated approval for AVLAYAH (tividenofusp alfa) to treat neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients ≥5 kg.
First FDA-approved biologic designed to cross the blood-brain barrier using TransportVehicle platform.
Approval based on 91% reduction in CSF heparan sulfate biomarker at week 24; 93% of patients reached normal range.
Most common adverse reaction: infusion-related reactions; continued approval contingent on confirmatory COMPASS trial.
FDA awarded Rare Pediatric Disease Priority Review Voucher (PRV) in connection with approval.

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