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 |
---|---|---|---|---|---|
2017/01/02 | Not Applicable | Terminated | |||
2016/12/28 | Phase 4 | Withdrawn | |||
2016/12/06 | Not Applicable | Completed | |||
2016/10/27 | Phase 3 | Completed | |||
2016/08/23 | Phase 4 | Terminated | Hospital Son Espases | ||
2016/07/11 | Phase 3 | Completed | |||
2016/06/23 | Phase 3 | Completed | |||
2016/06/16 | Phase 1 | Terminated | |||
2016/05/04 | Phase 2 | Completed | |||
2016/04/21 | Not Applicable | UNKNOWN | Huiqing Sun |
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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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S20113003 | 生物制品 | 注射剂 | 4/15/2020 | |
Human Erythropoietin Injection | 国药准字S20133004 | 生物制品 | 注射剂 | 4/26/2024 | |
Human Erythropoietin Injection | 国药准字S20083023 | 生物制品 | 注射剂 | 9/15/2020 | |
Human Erythropoietin Injection | 国药准字S20020044 | 生物制品 | 注射剂 | 9/15/2020 | |
Human Erythropoietin Injection | 国药准字S20000022 | 生物制品 | 注射剂 | 9/15/2020 | |
Human Erythropoietin Injection | 国药准字S20133020 | 生物制品 | 注射剂 | 1/13/2020 | |
Human Erythropoietin Injection | 国药准字S20020045 | 生物制品 | 注射剂 | 9/15/2020 |
PPB Drug Approvals
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TGA Drug Approvals
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