Xenpozyme(olipudase alfa)
Xenpozyme (olipudase alfa) is an enzyme pharmaceutical. Olipudase alfa was first approved as Xenpozyme on 2022-06-24. It is used to treat lysosomal storage diseases in the USA. It has been approved in Europe to treat multiple acyl coenzyme a dehydrogenase deficiency.
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Commercial
Trade Name
FDA
EMA
Xenpozyme
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)
Olipudase alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Xenpozyme | olipudase alfa-rpcp | Genzyme Corporation | N-761261 RX | 2022-08-31 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xenpozyme | Biologic Licensing Application | 2022-08-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lysosomal storage diseases | — | D016464 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
olipudase alfa, Xenpozyme, Genzyme Corporation | |||
| 2029-08-31 | Orphan excl. | ||
Patent Expiration
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ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type a niemann-pick disease | D052536 | EFO_1001380 | E75.240 | 2 | 3 | 1 | — | 2 | 6 |
Indications Phases 2
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OLIPUDASE ALFA |
| INN | olipudase alfa |
| Description | Olipudase alfa, sold under the brand name Xenpozyme, is a medication used for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) type A/B or type B.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707358 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12835 |
| UNII ID | 6D5766Q4OP (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 89 documents
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Safety
Black-box Warning
Black-box warning for: Xenpozyme
Adverse Events
Top Adverse Reactions
0 adverse events reported
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