Overview
Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.
Background
Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow . Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures . It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market . The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product . Epoetin alfa formulations can be administered intravenously or subcutaneously.
Indication
用于肾功能不全合并的贫血,艾滋病本身或因治疗引起的贫血,恶性肿瘤伴发的贫血及风湿性贫血等。另外,为择期手术储存自体血而反复采血的患者,同时应用本品可预防发生贫血。
Associated Conditions
- Anemia
- Blood Loss During Surgery
- Anemia caused by Zidovudine
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/05/27 | Phase 3 | Recruiting | |||
2022/05/04 | Early Phase 1 | Completed | |||
2022/04/13 | Phase 4 | Active, not recruiting | |||
2022/03/29 | Phase 4 | Active, not recruiting | United States Army Research Institute of Environmental Medicine | ||
2022/01/06 | Phase 1 | Recruiting | |||
2021/12/22 | Phase 2 | Completed | |||
2021/10/15 | Phase 3 | Active, not recruiting | University Hospital, Angers | ||
2021/07/13 | Phase 4 | Completed | Rufaida Mazahir | ||
2021/06/02 | Phase 3 | UNKNOWN | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2021/05/13 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Human Erythropoietin Injection | 国药准字S20053103 | 生物制品 | 注射剂 | 5/15/2020 | |
Human Erythropoietin Injection | 国药准字S20133012 | 生物制品 | 注射剂 | 4/30/2020 | |
Human Erythropoietin Injection | 国药准字S20133003 | 生物制品 | 注射剂 | 1/13/2020 | |
Human Erythropoietin Injection | 国药准字S20103002 | 生物制品 | 注射剂 | 1/13/2020 | |
Human Erythropoietin Injection | 国药准字S20020060 | 生物制品 | 注射剂(注射液) | 6/23/2021 | |
Human Erythropoietin Injection | 国药准字S20053105 | 生物制品 | 注射剂 | 5/15/2020 | |
Human Erythropoietin Injection | 国药准字S19980073 | 生物制品 | 注射剂 | 7/13/2020 | |
Human Erythropoietin Injection | 国药准字S20030021 | 生物制品 | 注射剂 | 2/22/2020 | |
Human Erythropoietin Injection | 国药准字S20153009 | 生物制品 | 注射剂 | 6/11/2020 | |
Human Erythropoietin Injection | 国药准字S20010041 | 生物制品 | 注射剂 | 4/26/2024 |
PPB Drug Approvals
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TGA Drug Approvals
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