Alglucosidase alfa

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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Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
hereditary congenital and neonatal diseases and abnormalities	D009358
nutritional and metabolic diseases	D009750

Trade Name

FDA

EMA

Lumizyme (discontinued: Myozyme)

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Alglucosidase alfa

Tradename	Proper name	Company	Number	Date	Products
Lumizyme	alglucosidase alfa	Sanofi	N-125291 RX	2010-05-24	1 products

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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

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

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	20	28	11	17	73	135
Glycogen storage disease	D006008	—	E74.0	4	7	2	3	22	35
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	—	11	5	7	23
Glycogen storage disease type iii	D006010	Orphanet_366	E74.03	1	2	2	7	3	15
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	5	3	—	8
Inborn errors carbohydrate metabolism	D002239	—	—	—	—	—	2	2	4
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	—	1	1	—	2
Diarrhea	D003967	—	R19.7	—	—	—	2	—	2
Heartburn	D006356	—	R12	—	—	—	1	—	1
Liver diseases	D008107	EFO_0001421	K70-K77	—	—	—	1	—	1

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Disease	D004194	EFO_0000408	R69	2	3	1	—	8	12
Deficiency diseases	D003677	EFO_1001067	E63	1	1	1	—	1	3
Chronic renal insufficiency	D051436	—	N18	—	—	1	—	—	1
Kidney diseases	D007674	EFO_0003086	N08	—	—	1	—	—	1
Insulin resistance	D007333	EFO_0002614	E88.819	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lysosomal storage diseases	D016464	—	—	2	2	—	—	7	10
Metabolic diseases	D008659	EFO_0000589	E88.9	2	3	—	—	5	8
Obesity	D009765	EFO_0001073	E66.9	—	1	—	—	1	2
Hypotension	D007022	EFO_0005251	I95	—	1	—	—	—	1
Syncope	D013575	—	G90.01	—	1	—	—	—	1
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	—	1	—	—	—	1
Motor neuron disease	D016472	EFO_0003782	G12.2	—	1	—	—	—	1
Sclerosis	D012598	—	—	—	1	—	—	—	1
Malnutrition	D044342	EFO_0008572	E40-E46	—	1	—	—	—	1
Rare diseases	D035583	—	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	2	—	—	—	2	4
Gaucher disease	D005776	Orphanet_355	E75.22	1	—	—	—	2	3
Mucopolysaccharidosis iv	D009085	—	E76.210	1	—	—	—	1	2
Wolman disease	D015223	Orphanet_75233	E75.5	1	—	—	—	1	2
Hypersensitivity	D006967	EFO_0003785	T78.40	1	—	—	—	1	2

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Muscular diseases	D009135	EFO_0002970	G72.9	—	—	—	—	5	5
Muscle weakness	D018908	—	—	—	—	—	—	3	3
Muscular dystrophies	D009136	EFO_0000757	G71.0	—	—	—	—	3	3
Myositis	D009220	EFO_0000783	G72.49	—	—	—	—	3	3
Pancreatitis	D010195	EFO_0000278	K85	—	—	—	—	2	2
Overweight	D050177	—	E66.3	—	—	—	—	2	2
Myotonic dystrophy	D009223	—	G71.11	—	—	—	—	2	2
Niemann-pick diseases	D009542	—	E75.24	—	—	—	—	2	2
Splenomegaly	D013163	—	R16.1	—	—	—	—	2	2
Muscular atrophy	D009133	—	—	—	—	—	—	2	2

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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)	—