Avalglucosidase alfa-ngpt_(Nexviazyme®)

Nexviazyme (avalglucosidase alfa‑ngpt) is covered only for the FDA‑approved treatment of late‑onset Pompe disease in patients aged ≥1 year and is not authorized for patients <1 year or for off‑label uses. Approval requires confirmed diagnosis by deficient GAA enzyme activity or GAA genetic testing, prescription by or consultation with a geneticist/neurologist/metabolic or lysosomal storage disorder specialist, documentation of age/weight/tests/specialist involvement, weight‑based dosing (≥30 kg: 20 mg/kg q2w; <30 kg: 40 mg/kg q2w), adherence to applicable safety criteria, and is authorized for 12 months.

"Nexviazyme (avalglucosidase alfa-ngpt) is indicated for the treatment of individuals with late-onset Pompe disease (lysosomal acid α-glucosidase deficiency)."

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