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
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 |
|---|---|---|---|---|---|
| Nexviazyme | avalglucosidase alfa-ngpt | Genzyme Corporation | N-761194 RX | 2021-08-06 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nexviazyme | Biologic Licensing Application | 2021-08-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| glycogen storage disease type ii | Orphanet_365 | D006009 | E74.02 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| C9085 | Injection, avalglucosidase alfa-ngpt, 4 mg |
Clinical
Clinical Trials
7 clinical trials
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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 ii | D006009 | Orphanet_365 | E74.02 | 1 | — | 1 | 1 | 1 | 4 |
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 iii | D006010 | Orphanet_366 | E74.03 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AVALGLUCOSIDASE ALFA |
| INN | avalglucosidase 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 class | enzymes |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1802558-87-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594320 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16099 |
| UNII ID | EO144CP0X9 (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 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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