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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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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
10 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
Alpha-mannosidosisD008363135—110
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
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1492823-75-2
RxCUI—
ChEMBL IDCHEMBL4298010
ChEBI ID—
PubChem CID—
DrugBankDB12374
UNII IDM91TG242P2 (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:
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Additional graphs summarizing 36 documents
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Safety
Black-box Warning
Black-box warning for: Lamzede
Adverse Events
Top Adverse Reactions
Mock data
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93,853 adverse events reported
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