Fabrazyme® (agalsidase beta)

Fabrazyme (agalsidase beta) is covered only for the FDA‑approved indication of Fabry disease (all other indications excluded) and is authorized for up to 12 months. Approval requires confirmed diagnosis by either deficient alpha‑galactosidase A activity or a pathogenic GLA variant, prescription or consultation by a geneticist, endocrinologist, metabolic disorder/lysosomal storage disorder specialist, and dosing at 1 mg/kg IV every 2 weeks.

"Fabrazyme (agalsidase beta) is indicated for the treatment of individuals with Fabry disease."

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