Last update 19 Jun 2024
Epoetin theta
Last update 19 Jun 2024
Overview
Basic Info
Drug Type Colony-stimulating factors |
Synonyms epoetin theta, Epoetin theta (INN), EpoTheta-Teva + [3] |
Target |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists), Erythropoiesis stimulants(Erythropoiesis stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date EU (23 Oct 2009), |
Regulation- |
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Gene Sequence
Sequence Code 8988
Related
1
Clinical Trials associated with Epoetin thetaEvaluation of the Safety of a Formulation Containing Epoetin (Epoetin STADA) Administered Intravenously for the Maintenance Treatment of Renal Anemia: an Open Follow-up Trial. Study code (CRO) 411-54-04-14-0000. - Epoetin STADA, Follow up
Start Date21 Mar 2005 |
Sponsor / Collaborator- |
100 Clinical Results associated with Epoetin theta
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100 Translational Medicine associated with Epoetin theta
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100 Patents (Medical) associated with Epoetin theta
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26
Literatures (Medical) associated with Epoetin theta01 Feb 2016·Clinical therapeuticsQ4 · MEDICINE
Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study
Q4 · MEDICINE
Article
Author: Bias, Peter ; Balcke, Peter ; Wiesholzer, Martin ; Mangold, Simone ; Lammerich, Andreas
PURPOSE:
The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia.
METHODS:
In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or end-stage renal disease and receiving epoetin theta were followed up for 6 months. Data on reportable adverse events (RAEs) (cardiac disorders, cardiac failure, myocardial infarction, and ischemic stroke and respective subterms), epoetin theta dosage, and Hb concentrations were collected. A post hoc exploratory analysis assessed the incidences of RAEs according to tertiles for individual mean Hb concentration (≤10.7, >10.7-11.47, and >11.47 g/dL for low, intermediate, and high, respectively) and mean weekly epoetin theta dosage (≤62, >62-125, and >125 IU/kg/wk for low, intermediate, and high).
FINDINGS:
Data from 1039 patients were included (577 men, 462 women; mean age, 68.7 years). A total of 101 RAEs were documented in 89 patients (8.6%), for an event rate of 0.1985/person-year. Sixty-four patients (6.1%) died; none of the deaths was considered related to epoetin theta use. The incidence of RAEs was lowest at intermediate Hb concentrations (6.2%) compared with low (11.3%) and high (7.8%) Hb concentrations. The incidence of ischemic stroke was 1.5% at high Hb concentrations versus 0.6% at both the low and intermediate Hb concentrations. The incidence of any RAE was greater in the high-dose group (10.1%) than in the intermediate-dose (8.0%) and low-dose (7.6%) groups. The risk for any cardiovascular RAE or ischemic stroke was greatest in the high-dose/high-Hb group (13.3%), followed by high dose/low Hb (12.6%) and low dose/low Hb (12.1%). The risks for RAEs were lowest at high dose/intermediate Hb (3.8%) and low dose/intermediate Hb (5.3%). The event rate of adverse drug reactions other than the predefined RAEs was 0.0161/person-year. No cases of pure red cell aplasia were reported.
IMPLICATIONS:
The findings from the present study suggest that, for maintaining the optimal target Hb concentration (10-12 g/dL according to the current summary of product characteristics for epoetin theta; 10-11.5 g/dL according to the current guideline from Kidney Disease Improving Global Outcomes) in anemic adults with CKD, the lowest approved, effective dose epoetin theta should be used.
01 Apr 2014·Clinical therapeuticsQ4 · MEDICINE
Dose Efficiency of Erythropoiesis-Stimulating Agents for the Treatment of Patients With Chemotherapy-Induced Anemia: A Systematic Review
Q4 · MEDICINE
Review
Author: Worthy, Gillian ; Kleijnen, Jos ; Van Belle, Simon ; Forbes, Carol A ; Harker, Julie ; Kutikova, Lucie ; Zelek, Laurent
BACKGROUND:
Erythropoiesis-stimulating agents (ESAs) increase red blood cell production in patients with chemotherapy-induced anemia (CIA). In Europe, short-acting ESAs (epoetin alfa, epoetin beta, epoetin zeta, and epoetin theta) and a long-acting ESA (darbepoetin alfa) are available to treat CIA.
OBJECTIVE:
This systematic review aimed to determine potential dose efficiency associated with the use of different ESAs for the treatment of CIA according to European labeling.
METHODS:
A systematic review of ESA studies with starting doses according to European labeling was conducted according to published methodology. Measures of dose efficiency were defined as mean weekly doses to achieve target hemoglobin level or final dose and dose adjustments (dose increase, decrease, or withheld). Electronic databases and grey literature sources were searched up to July 2012. Data were selected for analysis using an evidence hierarchy and quantitatively analyzed to assess statistical homogeneity. Where pooling of data was not appropriate, a narrative summary with descriptive statistics (medians and ranges) was reported.
RESULTS:
Fifty-five studies met the inclusion criteria. Twenty-five studies considered to represent the highest level of evidence were extracted and included in the analysis. The analysis showed a high degree of statistical heterogeneity, often precluding meta-analysis. The patients included in the analysis were representative of those encountered in clinical practice, and patient characteristics were similar between the short-acting and the darbepoetin alfa groups. Mean weekly doses appeared ~30% lower with darbepoetin alfa versus short-acting ESAs (median, 136.5 μg or 27,300 IU [range, 21,560-38,260 IU] vs 38,230 IU [range, 31,634-42,714 IU], respectively), resulting in a mean weekly dose ratio of 1:280. Darbepoetin alfa patients appeared to need fewer dose increases compared with short-acting ESAs (pooled, 0.75%; I(2) = 21% vs median 26.6% [range, 7.6%-44.6%]) and more dose decreases (median, 74% [range, 57%-75%] vs 22% [range, 2.8%-59%]). A similar percentage of darbepoetin alfa and short-acting ESA patients required a dose to be withheld (20% and 33% [2 studies] vs median 33.2% [range, 12.6%-51.1%]).
CONCLUSIONS:
Statistical heterogeneity between studies was high, although clinically the studies represented medical practice. Without randomized clinical trials directly comparing darbepoetin alfa and short-acting ESAs, these findings are tentative and future research is warranted. This review shows that good-quality, reliable data from head-to-head trials are lacking. The best available evidence comes from prospective ESA-arm data. Mean weekly doses, dose increases, and dose decreases suggest a dose efficiency for darbepoetin alfa compared with short-acting ESAs.
01 Jan 2014·Canadian journal of kidney health and disease
Efficacy and Safety Data of Subsequent Entry Biologics Pertinent to Nephrology Practice: A Systematic Review
Article
Author: Lo, Clifford ; Martinusen, Daniel J ; Leung, Marianna ; Marin, Judith Genevieve ; Tsao, Nicole W
Background::
Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians.
Objectives::
To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic.
Design::
Systematic review.
Sources of information::
Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials.
Patients::
Adult patients with chronic kidney disease (CKD).
Methods::
Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs), quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well.
Results::
Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta) were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic.
Limitations::
Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled results.
Conclusions::
Little clinical difference was found between epoetin SEBs and the reference product. Although not deemed clinically important, the financial implication of a possible dose difference between epoetin zeta and reference product should be considered in pharmacoeconomic studies. Ongoing trials are expected to address the risk of pure-red-cell aplasia with HX 575.
2
News (Medical) associated with Epoetin theta13 Feb 2024
DUBLIN--(
BUSINESS WIRE
)--The
"Injectable Hematology Growth Factors Report"
has been added to
ResearchAndMarkets.com's
offering.
This report is a comprehensive evaluation and analysis of the technology, products, and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision-makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, and opportunities for injection devices designed for patient self-administration. Provider organization business managers, healthcare administrators, and investors will also benefit from this study.
Evolution in Therapeutic Care
Several recombinant hematologic growth factors or agonists for their receptors have been produced that are useful in treating anemia, neutropenia, and thrombocytopenia, particularly in patients with end-stage renal disease or aplastic anemia or who have received cancer chemotherapy or a hematopoietic cell transplant.
The shift in as-supplied packaging from single and multi-use vials to prefilled injection devices will accelerate over the next five years as drug developers move to empower an increasing number of chronically ill patients. The powerful physiological effects of antibodies, hormones, and other biological drugs also increase the need for safety and compliance.
What You Will Learn
Provides detailed analysis of injectable hematology growth factors delivery and device strategies, and product development factors.
Assesses key markets, market dynamics, and market demographics.
Analyzes therapeutic demand drivers and evaluates injectable drug products in a number of key therapeutic segments.
Provides market data and forecasts.
Profiles market sector participants, their product development activities, business strategies, and corporate alliances and affiliations
Assesses the importance of alliances and partnerships on drug product commercialization.
Evaluates the impact of economic, technology, and regulatory factors
Key Topics Covered:
Hematology Market Dynamics
Competitive Factors
Proliferation of Biological Drugs
Product Manufacturers
Hematology Growth Factors
Devices for Administering Injectable Growth Factors
Device Selection - Stability and Material Issues
Competitive Landscape
Prefilled Syringes
Pen Injectors
Dual Chamber Pens
Emerging Devices
Injectable Hematology Growth Factors - Product Assessment
Abseamed
Accofil
Aranesp
Binocrit
Biograstim
Biopoin
Epoetin Alfa Hexal
Eporatio
Filgrastim Hexal
Fulphila
Granix
Grastofil
Mircera
NeoRecormon
Neulasta
Neupogen
Nivestim
Ratiograstim
Retacrit
Rolvedon
Silapo
Tevagrastim
Udenyca (Coherus BioSciences)
Zarzio
Ziextenzo
Market Assessment
Anemia
Hematopoietic Stem Cell Transplant
Advanced Kidney Disease
Neutropenia
Predonation of Autologous Blood
Company Profiles
Companies Mentioned
AbZ-Pharma
Accord Healthcare
Amgen
Genentech
Hexal AG
Medice Arzneimittel
Mylan International
Novartis
Pfizer
Ratiopharm
Rentscler Biotechnologie
Roche
Sandoz
Stada Arzneimittel AG
Teva Pharmaceuticals
For more information about this report visit
https://www.researchandmarkets.com/r/bktosb
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
ASH
09 Feb 2024
DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Injectable Hematology Growth Factors Report" has been added to
ResearchAndMarkets.com's offering.
Understanding the rapidly advancing sector of injectable hematology growth factors is crucial for stakeholders in the healthcare industry. The latest comprehensive report evaluates the intersection of technology, products, and key players that are shaping this dynamic segment, with particular emphasis on devices designed for patient self-administration.
The study presents an in-depth examination of the evolving therapeutic care landscape, highlighting significant developments in the treatment of conditions such as anemia, neutropenia, and thrombocytopenia. It analyzes the shift from traditional vials to prefilled injection devices, a trend that is likely to gain momentum over the following five years, emphasizing the market forces driving this change.
Key Highlights from the Report:
An in-depth analysis of device strategies and product development factors influencing the injectable hematology growth factors delivery systems.
Insight into market dynamics and demographics, underpinning industry growth.
An evaluation of therapeutic demand drivers across pivotal segments in healthcare.
Comprehensive market data and forecast trends to inform strategic decisions.
Profiles of sector participants including business strategies and corporate associations.
An assessment of how alliances and partnerships affect the commercialization of drug products.
Insights into the economic, technological, and regulatory factors impacting the market.
Healthcare administrators, investors, and other stakeholders will benefit from this study's findings that not only chart current market conditions but also project future industry directions. It serves as a critical resource for decision-makers aiming to understand and capitalize on the opportunities presented within this segment.
The report's findings are pivotal for a broad spectrum of healthcare professionals, including pharmaceutical decision-makers, device developers, healthcare marketers, and supply chain entities. It is particularly geared towards empowering chronically ill patients and enhancing safety protocols through revolutionary drug delivery methods.
Stakeholders are poised to gain substantial insights into the strategies propelling the adoption of injectable hematologic treatments, facilitating informed decisions that align with the compelling trends of self-administered therapeutic care.
Discover the Future of Injectable Hematology Treatments
As the healthcare industry continues its inexorable march towards more patient-centric and self-managed treatment options, understanding the nuances and intricacies of injectable hematology growth factor treatments becomes ever more critical. The recent report provides these vital insights, demarking a clear view of the path forward.
Stay informed on the latest in healthcare advancements and market opportunities. For further information and to explore the depth of this report, interested parties are encouraged to delve into the comprehensive analysis that awaits them.
Key Topics Covered:
Hematology Market Dynamics
Competitive Factors
Proliferation of Biological Drugs
Product Manufacturers
Hematology Growth Factors
Devices for Administering Injectable Growth Factors
Device Selection - Stability and Material Issues
Competitive Landscape
Prefilled Syringes
Pen Injectors
Dual Chamber Pens
Emerging Devices
Injectable Hematology Growth Factors - Product Assessment
Abseamed
Accofil
Aranesp
Binocrit
Biograstim
Biopoin
Epoetin Alfa Hexal
Eporatio
Filgrastim Hexal
Fulphila
Granix
Grastofil
Mircera
NeoRecormon
Neulasta
Neupogen
Nivestim
Ratiograstim
Retacrit
Rolvedon
Silapo
Tevagrastim
Udenyca (Coherus BioSciences)
Zarzio
Ziextenzo
Market Assessment
Anemia
Hematopoietic Stem Cell Transplant
Advanced Kidney Disease
Neutropenia
Predonation of Autologous Blood
Company Profiles
Companies Mentioned
AbZ-Pharma
Accord Healthcare
Amgen
Genentech
Hexal AG
Medice Arzneimittel
Mylan International
Novartis
Pfizer
Ratiopharm
Rentscler Biotechnologie
Roche
Sandoz
Stada Arzneimittel AG
Teva Pharmaceuticals
For more information about this report visit
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Media Contact:
Research and Markets
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ASH
100 Deals associated with Epoetin theta
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R&D Status
Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Not Applicable | 1,379 | rvcahclwux(cdmteknmjy) = only 27 patients (2%) experienced treatment-related adverse events, 2 of them (0.1%) presenting with a serious one (non fatal pulmonary embolism) usjgsetaef (qelydyumtk ) | Positive | 18 May 2017 |
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