Myozyme(alglucosidase alfa)
Lumizyme, Myozyme (alglucosidase alfa) is an enzyme pharmaceutical. Alglucosidase alfa was first approved as Myozyme on 2006-03-28. It is used to treat glycogen storage disease type II in the USA. It has been approved in Europe to treat glycogen storage disease type II.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Lumizyme (discontinued: Myozyme)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lumizyme | Biologic Licensing Application | 2025-01-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| glycogen storage disease type ii | Orphanet_365 | D006009 | E74.02 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
alglucosidase alfa, Myozyme, Genzyme Corporation | |||
| 2113-04-28 | Orphan excl. | ||
Patent Expiration
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Clinical
Clinical Trials
184 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 2 | 10 | 6 | 13 | 23 | 51 |
| Glycogen storage disease type iii | D006010 | Orphanet_366 | E74.03 | 1 | 2 | 2 | 7 | 3 | 15 |
| Glycogen storage disease | D006008 | — | E74.0 | 2 | 2 | 2 | 1 | 9 | 15 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 2 | — | 2 |
| Heartburn | D006356 | — | R12 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | 1 | 1 | 1 | — | 4 | 6 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | 1 | 1 | 1 | — | 1 | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anaphylaxis | D000707 | — | T78.2 | — | — | — | — | 1 | 1 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis ii | D016532 | — | E76.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alglucosidase alfa |
| INN | alglucosidase alfa |
| Description | Alglucosidase alfa, sold under the brand name Myozyme among others, is an enzyme replacement therapy (ERT) orphan drug for treatment of Pompe disease (Glycogen storage disease type II), a rare lysosomal storage disorder (LSD).
Chemically speaking, the drug is an analog of the enzyme that is deficient in patients affected by Pompe disease, alpha-glucosidase. It is the first drug available to treat this disease.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201824 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01272 |
| UNII ID | DTI67O9503 (ChemIDplus, GSRS) |
Target
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Trends
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Additional graphs summarizing 35,723 documents
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Safety
Black-box Warning
Black-box warning for: Lumizyme
Adverse Events
Top Adverse Reactions
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6,247 adverse events reported
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