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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
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
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)
Alglucosidase alfa
Tradename
Proper name
Company
Number
Date
Products
Lumizymealglucosidase alfaGenzyme CorporationN-125291 RX2010-05-24
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
lumizymeBiologic Licensing Application2021-03-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
glycogen storage disease type iiOrphanet_365D006009E74.02
Agency Specific
FDA
EMA
Expiration
Code
alglucosidase alfa, Myozyme, Genzyme Corporation
2113-04-28Orphan excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB07: Alglucosidase alfa
HCPCS
Code
Description
C9085
Injection, avalglucosidase alfa-ngpt, 4 mg
J0220
Injection, alglucosidase alfa, 10 mg, not otherwise specified
J0221
Injection, alglucosidase alfa, (lumizyme), 10 mg
Clinical
Clinical Trials
47 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 iiD006009Orphanet_365E74.02310511934
Glycogen storage disease type iiiD006010Orphanet_366E74.03—227112
Type 2 diabetes mellitusD003924EFO_0001360E11——42410
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E13——2——2
Glucose metabolism disordersD044882——1——1
Metabolic syndromeD024821EFO_0000195E88.81——1——1
Endocrine system diseasesD004700EFO_0001379E34.9——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Glycogen storage diseaseD006008E74.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameALGLUCOSIDASE ALFA
INNalglucosidase 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 classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID420784-05-0
RxCUI629565
ChEMBL IDCHEMBL1201824
ChEBI ID—
PubChem CID—
DrugBankDB01272
UNII IDDTI67O9503 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 779 documents
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Safety
Black-box Warning
Black-box warning for: Lumizyme
Adverse Events
Top Adverse Reactions
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63,582 adverse events reported
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