Elosulfase alfa - PharmaKB

Vimizim(elosulfase alfa)

Vimizim (elosulfase alfa) is an enzyme pharmaceutical. Elosulfase alfa was first approved as Vimizim on 2014-02-14. It is used to treat mucopolysaccharidosis IV in the USA. It has been approved in Europe to treat mucopolysaccharidosis IV.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
nutritional and metabolic diseases	D009750

Trade Name

FDA

EMA

Vimizim

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Elosulfase alfa

Tradename	Proper name	Company	Number	Date	Products
Vimizim	elosulfase alfa	BioMarin Pharmaceutical	N-125460 RX	2014-02-14	1 products

Labels

FDA

EMA

Brand Name	Status	Last Update
vimizim	Biologic Licensing Application	2021-01-21

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
mucopolysaccharidosis iv	—	D009085	E76.210

Agency Specific

FDA

EMA

Expiration	Code
elosulfase alfa, Vimizim, BioMarin Pharmaceutical Inc.
2121-02-14	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

— A16AB12: Elosulfase alfa

HCPCS

Code	Description
J1322	Injection, elosulfase alfa, 1 mg

Clinical

Clinical Trials

265 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	16	—	1	2	—	19
Immunologic deficiency syndromes	D007153	—	D84.9	1	3	8	1	3	13
Primary immunodeficiency diseases	D000081207	—	—	1	3	8	1	3	13
Diabetes mellitus	D003920	EFO_0000400	E08-E13	3	5	—	2	—	10
Dehydration	D003681	—	E86.0	1	1	1	6	1	10
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	3	3	—	3	—	9
Pain	D010146	EFO_0003843	R52	—	—	2	2	1	5
Cataract	D002386	EFO_0001059	H26.9	—	—	—	1	3	4
Strabismus	D013285	—	H50.2	—	—	—	1	—	1
Injection site reaction	D000075662	—	—	—	—	—	1	—	1

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101	—	C90.0	11	7	5	—	—	21
Plasma cell neoplasms	D054219	—	—	10	7	5	—	—	20
Breast neoplasms	D001943	EFO_0003869	C50	4	10	6	—	1	19
Lymphoma	D008223	—	C85.9	4	10	4	—	—	17
Mucopolysaccharidosis iv	D009085	—	E76.210	3	5	3	—	4	13
Mucopolysaccharidoses	D009083	—	E76.3	2	5	3	—	4	12
Non-small-cell lung carcinoma	D002289	—	—	2	3	5	—	—	10
Lung neoplasms	D008175	—	C34.90	2	3	5	—	1	10
Syndrome	D013577	—	—	1	5	2	—	3	10
B-cell lymphoma	D016393	—	—	3	6	1	—	—	9

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	6	6	—	—	—	10
Neoplasms	D009369	—	C80	7	5	—	—	—	9
Leukemia	D007938	—	C95	2	2	—	—	—	4
Recurrence	D012008	—	—	2	2	—	—	—	4
Non-hodgkin lymphoma	D008228	—	C85.9	2	1	—	—	—	3
B-cell lymphoma marginal zone	D018442	—	C88.4	1	2	—	—	—	3
Large b-cell lymphoma diffuse	D016403	—	C83.3	2	2	—	—	—	3
Hypersensitivity	D006967	EFO_0003785	T78.40	2	1	—	—	—	3
Male breast neoplasms	D018567	—	—	—	3	—	—	—	3
Hodgkin disease	D006689	—	C81	1	2	—	—	—	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	4	—	—	—	—	4
Drug hypersensitivity	D004342	EFO_0009482	T88.7	3	—	—	—	—	3
Neuralgia	D009437	EFO_0009430	—	2	—	—	—	1	3
Myeloid leukemia acute	D015470	—	C92.0	2	—	—	—	—	2
Myeloid leukemia	D007951	—	C92	2	—	—	—	—	2
Carpal tunnel syndrome	D002349	EFO_0004143	G56.0	1	—	—	—	1	2
Systemic scleroderma	D012595	EFO_0000717	M34	2	—	—	—	—	2
Localized scleroderma	D012594	EFO_1001361	L94.0	2	—	—	—	—	2
Microstomia	D008865	—	Q18.5	2	—	—	—	—	2
Cholangiocarcinoma	D018281	—	C22.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infertility	D007246	EFO_0000545	—	—	—	—	—	3	3
Ocular hypotension	D015814	—	H44.4	—	—	—	—	2	2
Periodontitis	D010518	EFO_0000649	K05.3	—	—	—	—	2	2
Wounds and injuries	D014947	—	T14.8	—	—	—	—	2	2
Glaucoma	D005901	EFO_0000516	H40	—	—	—	—	1	1
Multiple sclerosis	D009103	EFO_0003885	G35	—	—	—	—	1	1
Relapsing-remitting multiple sclerosis	D020529	EFO_0003929	—	—	—	—	—	1	1
Sclerosis	D012598	—	—	—	—	—	—	1	1
Covid-19	D000086382	—	U07.1	—	—	—	—	1	1
Failed back surgery syndrome	D055111	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Elosulfase alfa
INN	elosulfase alfa
Description	Elosulfase alfa, sold under the brand name Vimizim, is a medication used for the treatment of Morquio syndrome which is caused by a deficiency in the enzyme N-acetylgalactosamine-6-sulfatase. Elosulfase alfa is a synthetic version of this enzyme.
Classification	Enzyme
Drug class	enzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—