Mepsevii(vestronidase alfa)
Mepsevii (vestronidase alfa) is an enzyme pharmaceutical. Vestronidase alfa was first approved as Mepsevii on 2017-11-15. It has been approved in Europe to treat mucopolysaccharidosis VII.
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Commercial
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Mepsevii
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)
Vestronidase alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Mepsevii | vestronidase alfa-vjbk | Ultragenyx | N-761047 RX | 2017-11-15 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mepsevii | Biologic Licensing Application | 2022-07-22 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
vestronidase alfa, Mepsevii, Ultragenyx Pharamceutical Inc. | |||
| 2024-11-15 | Orphan excl. | ||
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J3397 | Injection, vestronidase alfa-vjbk, 1 mg |
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidoses | D009083 | — | E76.3 | 1 | 2 | 2 | — | 3 | 7 |
| Mucopolysaccharidosis vii | D016538 | — | E76.29 | — | 1 | 2 | — | 2 | 5 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis ii | D016532 | — | E76.1 | 1 | 1 | — | — | 1 | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | 1 | — | — | — | — | 1 |
| Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | 1 | — | — | — | — | 1 |
| Wolman disease | D015223 | Orphanet_75233 | E75.5 | 1 | — | — | — | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Vestronidase alfa |
| INN | vestronidase alfa |
| Description | Vestronidase alfa, sold under brand name Mepsevii, is a drug for the treatment of Sly syndrome. It is a recombinant form of the human enzyme beta-glucuronidase. It was approved in the United States in November 2017, to treat children and adults with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and organs.
|
| Classification | Enzyme |
| Drug class | enzymes; estrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | 1989819 |
| ChEMBL ID | CHEMBL3707382 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 7XZ4062R17 (ChemIDplus, GSRS) |
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Additional graphs summarizing 97 documents
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Safety
Black-box Warning
Black-box warning for: Mepsevii
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44 adverse events reported
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