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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Commercial
Trade Name
FDA
EMA
Vimizim
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)
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 | 2020-04-14 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
elosulfase alfa, Vimizim, BioMarin Pharmaceutical Inc. | |||
| 2121-02-14 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1322 | Injection, elosulfase alfa, 1 mg |
Clinical
Clinical Trials
103 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 3 | 3 | — | 2 | — | 8 |
| Dehydration | D003681 | E86.0 | 1 | — | 1 | 4 | — | 6 | |
| Healthy volunteers/patients | — | 2 | — | — | 1 | — | 3 | ||
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | 2 | — | 3 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | 1 | — | 1 |
| Edema | D004487 | R60.9 | — | — | — | 1 | — | 1 | |
| Surgical wound infection | D013530 | — | — | — | 1 | — | 1 | ||
| Trismus | D014313 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis iv | D009085 | E76.210 | 2 | 5 | 3 | — | 3 | 11 | |
| Multiple myeloma | D009101 | C90.0 | 4 | 1 | 2 | — | 1 | 7 | |
| Non-small-cell lung carcinoma | D002289 | 1 | 1 | 2 | — | — | 4 | ||
| Primary immunodeficiency diseases | D000081207 | 1 | 2 | 2 | — | — | 3 | ||
| Postoperative pain | D010149 | G89.18 | — | 1 | 1 | — | 2 | 3 | |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | 2 | — | — | 3 | |
| Pancreatic ductal carcinoma | D021441 | 1 | — | 1 | — | — | 2 | ||
| Vitreous hemorrhage | D014823 | EFO_0008626 | H43.1 | — | — | 2 | — | — | 2 |
| B-cell lymphoma | D016393 | — | — | 1 | — | — | 1 | ||
| Bursitis | D002062 | EFO_1000941 | M71.9 | — | — | 1 | — | — | 1 |
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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 | 1 | 2 | — | — | — | 3 |
| Follicular lymphoma | D008224 | C82 | 2 | 2 | — | — | — | 3 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 2 | 2 | — | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 3 | — | — | — | 3 |
| Mantle-cell lymphoma | D020522 | C83.1 | — | 2 | — | — | — | 2 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 1 | — | — | — | 2 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 2 | — | — | — | 2 | |
| Melanoma | D008545 | — | 1 | — | — | — | 1 | ||
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | — | — | — | 1 |
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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 | 2 | — | — | — | — | 2 |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | 2 | — | — | — | — | 2 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
| Burkitt lymphoma | D002051 | C83.7 | 1 | — | — | — | — | 1 | |
| Localized scleroderma | D012594 | L94.0 | 1 | — | — | — | — | 1 | |
| Crest syndrome | D017675 | M34.1 | 1 | — | — | — | — | 1 | |
| Microstomia | D008865 | HP_0000160 | Q18.5 | 1 | — | — | — | — | 1 |
| Scleromyxedema | D053718 | L98.5 | 1 | — | — | — | — | 1 | |
| Hemolytic anemia | D000743 | D55-D59 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intraocular pressure | D007429 | — | — | — | — | 1 | 1 |
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) | — |
Identifiers
| PDB | — |
| CAS-ID | 9025-60-9 |
| RxCUI | 1489914 |
| ChEMBL ID | CHEMBL2108676 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09051 |
| UNII ID | ODJ69JZG85 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vimizim - BioMarin Pharmaceutical
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 258 documents
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Safety
Black-box Warning
Black-box warning for: Vimizim
Adverse Events
Top Adverse Reactions
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562 adverse events reported
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