Evaluation 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

100 Translational Medicine associated with Epoetin theta

100 Patents (Medical) associated with Epoetin theta

113

Literatures (Medical) associated with Epoetin theta

01 Nov 2024·Drug testing and analysis

Evaluation of a single Eporatio® micro‐dose in urine and dried blood spots

Article

Author: Heiland, Carmel E. ; Börjesson, Annica ; Lehtihet, Mikael ; Ekström, Lena

Abstract:

Recombinant human erythropoietin (rhEPO) has been abused as a performance enhancer in sports for several years, but with advancements in detection methods, even micro‐doses can be detected in dried blood spot (DBS) samples. Here, we present the results from an Eporatio® (epoetin theta) micro‐dose administration study to detect rhEPO in DBS samples. Five healthy male volunteers received a 15 IU/kg subcutaneous dose of Eporatio®. Urine and DBS samples (Mitra® VAMS and Capitainer® B50) were collected 1, 10, 24, 36, 48 and 72 h after drug administration. After 1 h, all urine samples were negative for rhEPO, whereas 40% of DBS samples were considered suspicious. All samples between 10 and 48 h were suspicious for the presence of Eporatio®, except one urine sample that was negative at 48 h. After 72 h, 40% of urine samples and 60% of DBS samples were suspicious and would have proceeded to a confirmation analysis. DBS is an efficient complementary matrix to urine for detection of rhEPO micro‐doses.

06 Jul 2023·Health research policy and systems

The impact of policy interventions to promote the uptake of biosimilar medicines in Belgium: a nationwide interrupted time series analysis.

Article

Author: Huys, Isabelle ; Van Wilder, Philippe ; Simoens, Steven ; Vandenplas, Yannick ; Vulto, Arnold G

BACKGROUND:

The Belgian government has taken several measures to increase the uptake of biosimilars in past years. However, no formal evaluation of the impact of these measures has been made yet. This study aimed to investigate the impact of the implemented measures on biosimilar uptake.

METHODS:

An interrupted time series analysis was performed using an autoregressive integrated moving average (ARIMA) model with the Box-Jenkins method. All data were expressed as defined daily doses (DDD) per month/quarter and obtained from the Belgian National Institute for Health and Disability Insurance (NIHDI). Three molecules were included in the analysis: etanercept (ambulatory), filgrastim (hospital), and epoetin (hospital). A significance level of 5% was used for all analyses.

RESULTS:

In the ambulatory care, the effect of a financial prescriber incentive of 2019 was investigated. After this intervention, 44.504 (95% CI -61.61 to -14.812; P < 0.001) fewer etanercept biosimilar DDDs were dispensed monthly than expected in the absence of the intervention. Two interventions were modelled for biosimilars in the hospital setting. The first intervention of 2016 includes prescription targets for biosimilars and monitoring of hospitals on adequate tendering. The second intervention involves an information campaign on biosimilars. After the first intervention, a small decrease in quarterly epoetin biosimilar uptake of 449.820 DDD (95% CI -880.113 to -19.527; P = 0.05) was observed. The second intervention led to a larger increase in quarterly epoetin biosimilar uptake of 2733.692 DDD (95% CI 1648.648-3818.736; P < 0.001). For filgrastim, 1809.833 DDD (95% CI 1354.797-2264.869; P < 0.001) more biosimilars were dispensed immediately after the first intervention and 151.639 DDD (95% CI -203.128 to -100.150; P < 0.001) fewer biosimilars each quarter after the first intervention. An immediate and sustained increase of 700.932 DDD (95% CI 180.536-1221.328; P = 0.016) in quarterly biosimilar volume was observed after the second intervention. All other parameter estimates were not statistically significant.

CONCLUSIONS:

The results of this study suggest that the impact of past policy interventions to increase the uptake of biosimilars has been variable and limited. A holistic policy framework is required to develop a competitive and sustainable off-patent biologicals market in Belgium.

01 Apr 2022·The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG

Epoetin alfa in Pediatric Patients With Ventricular Assist Devices: Is It Safe?

Article

Author: Jarosz, Audrey ; Hughes, Kaitlynn ; Peng, David M. ; Huebschman, Ashley

Anemia is a predictor of morbidity and mortality in both pediatric and adult patients with heart failure. This risk is increased in patients who require ventricular assist device (VAD) placement. The most common mechanism suggested for why these patients develop anemia is chronic inflammation caused by the immune system reacting to the VAD components. The inflammatory response that occurs can suppress erythropoiesis by inhibiting production of erythropoietin. Studies have demonstrated that anemic VAD patients have lower-than-expected erythropoietin levels, which leads to the consideration of erythropoiesis-stimulating agents (ESAs) in this population. Therapy with ESAs can increase hemoglobin and hematocrit levels, thereby decreasing the need for transfusions, subsequently reducing the risk of anti–human leukocyte antigen antibody development. Concerns that ESAs may increase the risk of thrombotic complications in a population already plagued with physiologic disturbances due to the VAD device remain a main barrier in routine use of these medications. The goal of this case series is to discuss a single center's experience with epoetin alfa in pediatric VAD patients at an academic children's hospital. A total of 4 patients were included with no evidence of adverse effects during a total of 120 patient-days of epoetin therapy. One patient was able to discontinue ESA therapy secondary to robust improvement in cell line counts at the time of discharge, while the other 3 patients received heart transplant prior to the discontinuation of ESA therapy. An increase in hematocrit of 1% to 5.5% was seen from epoetin initiation to discontinuation.

News (Medical) associated with Epoetin theta

13 Feb 2024

·www.businesswire.com

Injectable Hematology Growth Factors Report 2024 - Evolution in Therapeutic Care - ResearchAndMarkets.com

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

·www.prnewswire.com

Injectable Hematology Growth Factors Report: Shift in As-Supplied Packaging from Single and Multi-use Vials to Prefilled Injection Devices will Accelerate over the Next Five Years

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 Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

ASH

100 Deals associated with Epoetin theta

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KEGG	Wiki	ATC	Drug Bank
D10846	-	B03XA01	DB00016

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	European Union	Teva GmbH	23 Oct 2009
Anemia	Iceland	Teva GmbH	23 Oct 2009
Anemia	Liechtenstein	Teva GmbH	23 Oct 2009
Anemia	Norway	Teva GmbH	23 Oct 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SP609 (ERA2017)	Not Applicable	-	603	Epоetin alpha	mxbnsvahye(tfybhezazt) = augwoaunse vfpiznvcfx (dabnwwrgei ) View more	Negative	26 May 2017
SP609 (ERA2017)	Not Applicable	-	603	Epоetin beta	mxbnsvahye(tfybhezazt) = vdcbawvelg vfpiznvcfx (dabnwwrgei ) View more	Negative	26 May 2017
PIVOINE (EHA2017)	Not Applicable	Anemia	1,379	Epoetin theta	bugheyvslh(ejeksjubgp) = only 27 patients (2%) experienced treatment-related adverse events, 2 of them (0.1%) presenting with a serious one (non fatal pulmonary embolism) dgcmvdpmta (ckpgjqjfxq )	Positive	18 May 2017

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