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Myozyme

Alglucosidase Alfa · also sold as Myozyme / Lumizyme

An intravenous enzyme replacement therapy used to treat patients with Pompe disease.

Generic name
Alglucosidase Alfa
Brand names
Myozyme / Lumizyme
Marketed by
Sanofi (Genzyme)
First FDA approval
28 Apr 2006

Where Alglucosidase Alfa is approved

All regulators →

Of the three regulators tracked here, the first to approve Alglucosidase Alfa was the EU, on 28 Mar 2006. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
28 Apr 2006
Myozyme
BLA125141 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
28 Mar 2006
Myozyme
EMA product page
First centralised authorisation
CACanada (Health Canada)
14 Aug 2006
Myozyme
Notice of Compliance 8204
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Alglucosidase Alfa

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$54.4m
1,229 prescriptions in 2025 · Lumizyme
-11% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Alglucosidase Alfa works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Respiratory insufficiency due to muscle weaknessPhase 3

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201824, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7561, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Alglucosidase Alfa

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 1 product on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Myozyme
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Alglucosidase Alfa

ATC code
A16AB07
ChEMBL
CHEMBL1201824
DrugBank
DB01272
CAS number
420784-05-0
FDA UNII
DTI67O9503
Wikidata
Q2919537
Wikipedia
Alglucosidase alfa

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Myozyme is used for

Alglucosidase Alfa (Myozyme / Lumizyme) is an intravenous enzyme replacement therapy used to treat patients with Pompe disease. It belongs to the Enzyme replacement therapy class.

Related clinical trials recruiting now

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.