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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
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
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
Mepseviivestronidase alfa-vjbkUltragenyx Pharamceutical Inc.N-761047 RX2017-11-15
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
mepseviiBiologic Licensing Application2020-12-23
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
vestronidase alfa, Mepsevii, Ultragenyx Pharamceutical Inc.
2024-11-15Orphan 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
— A16AB18: Vestronidase alfa
HCPCS
Code
Description
J3397
Injection, vestronidase alfa-vjbk, 1 mg
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis viiD016538E76.29—12—14
MucopolysaccharidosesD009083E76.3—12——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis iiD016532E76.111——12
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVESTRONIDASE ALFA
INNvestronidase 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 classenzymes; estrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI1989819
ChEMBL IDCHEMBL3707382
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID7XZ4062R17 (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:
Mock data
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Additional graphs summarizing 70 documents
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Safety
Black-box Warning
Black-box warning for: Mepsevii
Adverse Events
Top Adverse Reactions
Mock data
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81 adverse events reported
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