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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5475 | 1802558-87-7 |
| Molecule | Description |
|---|---|
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Synonyms:
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Avalglucosidase alfa-ngpt provides an exogenous source of GAA. The M6P on avalglucosidase alfa-ngpt mediates binding to M6P receptors on the cell surface with high affinity. After binding, it is internalized and transported into lysosomes where it undergoes proteolytic cleavage that results in increased GAA enzymatic activity. Avalglucosidase alfa-ngpt then exerts enzymatic activity in cleaving glycogen.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 6, 2021 | FDA | GENZYME CORP | |
| Sept. 27, 2021 | PMDA | SANOFI K.K. | |
| June 24, 2022 | EMA | GENZYME EUROPE BV |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug specific antibody present | 447.34 | 37.06 | 69 | 604 | 5445 | 90622329 |
| Urinary hexose tetrasaccharide increased | 61.83 | 37.06 | 6 | 667 | 4 | 90627770 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug specific antibody present | 291.39 | 41.23 | 50 | 552 | 3956 | 42616777 |
| Urinary hexose tetrasaccharide increased | 47.39 | 41.23 | 5 | 597 | 5 | 42620728 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug specific antibody present | 722.30 | 38.62 | 117 | 1119 | 8317 | 110579746 |
| Urinary hexose tetrasaccharide increased | 86.46 | 38.62 | 9 | 1227 | 11 | 110588052 |
| Inappropriate schedule of product administration | 52.57 | 38.62 | 31 | 1205 | 203606 | 110384457 |
| Weight increased | 50.94 | 38.62 | 40 | 1196 | 419604 | 110168459 |
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| Source | Code | Description |
|---|---|---|
| ATC | A16AB22 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Enzymes |
| FDA CS | M0000794 | alpha-Glucosidases |
| FDA EPC | N0000175821 | Hydrolytic Lysosomal Glycogen-specific Enzyme |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pompe disease | indication | 274864009 | |
| Late-onset Pompe disease | indication | 722343009 |
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| ID | Source |
|---|---|
| EO144CP0X9 | UNII |
| C5418318 | UMLSCUI |
| CHEBI:757819 | CHEBI |
| CHEMBL4594320 | ChEMBL_ID |
| DB16099 | DRUGBANK_ID |
| D11744 | KEGG_DRUG |
| 10416 | INN_ID |
| C000731975 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1172659000 | SNOMEDCT_US |
| 1172664001 | SNOMEDCT_US |
| 4040754 | VANDF |
| 4040755 | VANDF |
| 349118 | MMSL |
| 39767 | MMSL |
| d09782 | MMSL |
| 018824 | NDDF |
| 2565813 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Nexviazyme | HUMAN PRESCRIPTION DRUG LABEL | 1 | 58468-0426 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100 mg | INTRAVENOUS | BLA | 28 sections |