Ropeginterferon alfa-2b
Besremi (ropeginterferon alfa-2b) is an unknown pharmaceutical. Ropeginterferon alfa-2b was first approved as Besremi on 2019-02-15. It is used to treat polycythemia vera in the USA. It has been approved in Europe to treat polycythemia vera.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Besremi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| besremi | Biologic Licensing Application | 2024-04-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| polycythemia vera | — | D011087 | D45 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ropeginterferon alfa-2b, Besremi, PharmaEssentia Corporation | |||
| 2028-11-12 | Orphan excl. | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycythemia vera | D011087 | — | D45 | 1 | 4 | 6 | 1 | 1 | 12 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 4 | 6 | 1 | 1 | 12 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | 1 | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary myelofibrosis | D055728 | — | D47.4 | — | 3 | 1 | — | — | 4 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | — | 1 | — | 1 | 3 |
| Essential thrombocythemia | D013920 | — | D47.3 | — | 1 | 2 | — | — | 3 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | — | 1 | 2 | — | — | 3 |
| Hepatitis c | D006526 | — | B19.2 | 1 | 1 | 1 | — | — | 3 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | 1 | 1 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | 1 | — | — | 2 |
| Communicable diseases | D003141 | — | — | 1 | — | 1 | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | — | 1 | — | — | 2 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis | D006505 | HP_0012115 | K75.9 | 2 | 2 | — | — | 1 | 5 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 2 | — | — | 1 | 5 |
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | 1 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 1 |
| Coinfection | D060085 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 1 | — | — | — | 1 | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | — | — | — | 1 | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Chronic hepatitis d | D019701 | — | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ropeginterferon alfa-2b |
| INN | ropeginterferon alfa-2b |
| Description | Ropeginterferon alfa-2b, sold under the brand name Besremi, is a medication used to treat polycythemia vera. It is an interferon. It is given by injection.
|
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1335098-50-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297819 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15119 |
| UNII ID | 981TME683S (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Additional graphs summarizing 139 documents
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Safety
Black-box Warning
Black-box warning for: Besremi
Adverse Events
Top Adverse Reactions
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1,254 adverse events reported
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