Mircera(methoxy polyethylene glycol-epoetin beta)
Mircera (methoxy polyethylene glycol-epoetin beta) is a protein pharmaceutical. Methoxy polyethylene glycol-epoetin beta was first approved as Mircera on 2007-07-20. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia and chronic kidney failure.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Mircera (discontinued: Mircera)
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 |
|---|---|---|
| mircera | Biologic Licensing Application | 2024-06-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anemia | EFO_0004272 | D000740 | D64.9 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
119 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | 10 | 49 | 16 | 18 | 93 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 4 | 11 | 6 | 16 | 37 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 3 | 8 | 5 | 16 | 32 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | 3 | 2 | 6 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 3 | 2 | 1 | 6 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | 1 | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | 1 | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | — | 1 | — | — | 1 |
| Peritoneal dialysis | D010530 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | 1 | — | — | — | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Reticulocyte count | D017701 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acidosis | D000138 | EFO_1000014 | E87.2 | — | — | — | — | 1 | 1 |
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | — | — | 1 | 1 |
| Renal tubular acidosis | D000141 | — | N25.89 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methoxy polyethylene glycol-epoetin beta |
| INN | — |
| Description | Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA).
|
| Classification | Protein |
| Drug class | erythropoietins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707314 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09107 |
| UNII ID | — |
Target
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Variants
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Financial
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Mircera – Roche
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 378 documents
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Safety
Black-box Warning
Black-box warning for: Mircera
Adverse Events
Top Adverse Reactions
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10,433 adverse events reported
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