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Nexviazyme, Nexviadyme(avalglucosidase alfa)
Nexviadyme, Nexviazyme (avalglucosidase alfa) is an enzyme pharmaceutical. Avalglucosidase alfa was first approved as Nexviazyme on 2021-08-06. It is used to treat glycogen storage disease type II in the USA. It has been approved in Europe to treat glycogen storage disease type II.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Nexviazyme
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)
Avalglucosidase alfa
Tradename
Proper name
Company
Number
Date
Products
Nexviazymeavalglucosidase alfa-ngptGenzyme CorporationN-761194 RX2021-08-06
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
nexviazyme Biologic Licensing Application2021-08-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
glycogen storage disease type iiOrphanet_365D006009E74.02
Agency Specific
FDA
EMA
No data
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
— A16AB22: Avalglucosidase alfa
HCPCS
Code
Description
C9085
Injection, avalglucosidase alfa-ngpt, 4 mg
Clinical
Clinical Trials
7 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Glycogen storage disease type iiD006009Orphanet_365E74.021—1114
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Glycogen storage disease type iiiD006010Orphanet_366E74.031————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAVALGLUCOSIDASE ALFA
INNavalglucosidase alfa
Description
Avalglucosidase alfa, sold under the brand name Nexviazyme, is an enzyme replacement therapy medication used for the treatment of glycogen storage disease type II (Pompe disease).
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1802558-87-7
RxCUI—
ChEMBL IDCHEMBL4594320
ChEBI ID—
PubChem CID—
DrugBankDB16099
UNII IDEO144CP0X9 (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 52 documents
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Safety
Black-box Warning
Black-box warning for: Nexviazyme
Adverse Events
Top Adverse Reactions
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2 adverse events reported
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