Galsulfase (Naglazyme)

Naglazyme (galsulfase) is covered only for the FDA‑approved indication mucopolysaccharidosis type VI (MPS VI/Maroteaux‑Lamy Syndrome); other indications are not covered. Approval requires enzyme assay showing deficient N‑acetylgalactosamine 4‑sulfatase (arylsulfatase B) activity or molecular genetic confirmation, prescription or consultation with a geneticist/endocrinologist/metabolic or lysosomal storage disorder specialist, is authorized for 12 months, and dosing is limited to 1 mg/kg IV no more frequently than once weekly.

"Naglazyme (galsulfase) is indicated for the treatment of mucopolysaccharidosis type VI (MPS VI; Maroteaux-Lamy Syndrome)."

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