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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Commercial
Therapeutic Areas
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nexviazyme | Biologic Licensing Application | 2025-06-05 |
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 |
|---|---|
| J0219 | Injection, avalglucosidase alfa-ngpt, 4 mg |
Clinical
Clinical Trials
52 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 | 4 | 12 | 7 | 15 | 18 | 52 |
| Glycogen storage disease type iii | D006010 | Orphanet_366 | E74.03 | 1 | 2 | 2 | 7 | 3 | 15 |
| Glycogen storage disease | D006008 | — | E74.0 | 3 | 3 | 1 | 3 | 7 | 15 |
| Heartburn | D006356 | — | R12 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | 1 | 1 | 1 | — | 2 | 4 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | 1 | 1 | 1 | — | 1 | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | 1 | — | — | — | — | 1 |
| Mucopolysaccharidosis vi | D009087 | — | — | 1 | — | — | — | — | 1 |
| Sudden infant death | D013398 | — | — | 1 | — | — | — | — | 1 |
| Mucopolysaccharidosis vii | D016538 | — | E76.29 | 1 | — | — | — | — | 1 |
| Wolman disease | D015223 | Orphanet_75233 | E75.5 | 1 | — | — | — | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anaphylaxis | D000707 | — | T78.2 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis ii | D016532 | — | E76.1 | — | — | — | — | 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
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Variants
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Financial
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Nexviazyme – Sanofi
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 767 documents
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Safety
Black-box Warning
Black-box warning for: Nexviazyme
Adverse Events
Top Adverse Reactions
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1,207 adverse events reported
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