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Drug ReportsVelmanase alfa
Lamzede(velmanase alfa)
Lamzede (velmanase alfa) is an enzyme pharmaceutical. Velmanase alfa was first approved as Lamzede on 2018-03-23. It is used to treat alpha-mannosidosis in the USA. It has been approved in Europe to treat alpha-mannosidosis.
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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Lamzede
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)
Velmanase alfa
Tradename
Proper name
Company
Number
Date
Products
Lamzedevelmanase alfa-tycvChiesi FarmaceuticiN-761278 RX2023-02-16
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
lamzedeBiologic Licensing Application2023-02-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
alpha-mannosidosis—D008363—
Agency Specific
FDA
EMA
Expiration
Code
velmanase alfa, Lamzede, Chiesi Farmaceutici S.p.A.
2030-02-16Orphan 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
— A16AB15: Velmanase alfa
HCPCS
No data
Clinical
Clinical Trials
11 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
Alpha-mannosidosisD008363———13—26
Mannosidase deficiency diseasesD044904—E77.1—13—26
Indications Phases 2
No data
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 nameVelmanase alfa
INNvelmanase alfa
Description
Velmanase alfa, sold under the brand name Lamzede, is a medication used for the treatment of alpha-mannosidosis. Velmanase alfa is a recombinant human lysosomal alpha-mannosidase.
Classification
Enzyme
Drug classenzymes
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4298010
ChEBI ID—
PubChem CID—
DrugBankDB12374
UNII IDM91TG242P2 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 85 documents
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Safety
Black-box Warning
Black-box warning for: Lamzede
Adverse Events
Top Adverse Reactions
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38 adverse events reported
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