Delving into the Latest Updates on Recombinant erythropoietin biosimilar(Elea Spa) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Human recombinant erythropoietin, Pronivel, Recombinant erythropoietin biosimilar

+ [1]

Target

EPO receptor

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Anemia

Inactive Indication-

Originator Organization

Elea Spa

Active Organization

Elea Spa

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

AR (01 Jan 2009),

Anemia

Regulation-

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Gene Sequence

Sequence Code 9003

The sequence is quoted from: *****

The purpose of this study is to establish the safety of the combined drug approach (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta, C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce ischemia-reperfusion injury during liver transplantation in eligible recipients.

Start Date01 Aug 2013

Sponsor / Collaborator-

IRCT201112265110N2 / CompletedPhase 2/3IIT

Evaluation of the Effect of Human Recombinant Erythropoietin on Reducing Need to Blood Transfusion in Very-Low-Birth-Weight Infants

Start Date08 Dec 2008

Sponsor / Collaborator-

IRCT138711201162N13 / CompletedPhase 2IIT

Effect of high versus low dose of human recombinant erythropoietin on the Anemia of prematurity

Start Date04 May 2001

Sponsor / Collaborator

Mashhad University of Medical Sciences

100 Clinical Results associated with Recombinant erythropoietin biosimilar(Elea Spa)

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100 Translational Medicine associated with Recombinant erythropoietin biosimilar(Elea Spa)

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100 Patents (Medical) associated with Recombinant erythropoietin biosimilar(Elea Spa)

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334

Literatures (Medical) associated with Recombinant erythropoietin biosimilar(Elea Spa)

01 Jan 2023·Transfusion Medicine and Hemotherapy

Patient Blood Management in Pregnancy

Review

Author: Breymann, Christian ; Kaserer, Alexander ; Henckert, David ; Spahn, Donat R ; Castellucci, Clara

Background: Patient blood management (PBM) is a multidisciplinary and patient-centered treatment approach, comprising the detection and treatment of anemia, the minimization of blood loss, and the rational use of allogeneic transfusions. Pregnancy, delivery, and the puerperium are associated with increased rates of iron deficiency and anemia, which correlates with worse maternal and fetal outcomes and places pregnant women at increased risk of obstetric hemorrhage. Summary: Early screening for iron deficiency before the onset of anemia, as well as the use of oral and intravenous iron to treat iron deficiency anemia, has been shown to be beneficial. Anemia in pregnancy and the puerperium should be treated according to a staged regimen, administering either iron alone or in combination with an off-label use of human recombinant erythropoietin in selected patients. This regimen should be tailored to the needs of each individual patient. Postpartum hemorrhage (PPH) accounts for up to one-third of maternal deaths in both developing and developed countries. Bleeding complications should be anticipated and blood loss reduced by interdisciplinary preventive measures and individually tailored care. It is recommended that facilities have a PPH algorithm, primarily focusing on prevention through use of uterotonics, but also incorporating early diagnosis of the cause of bleeding, optimization of hemostatic conditions, timely administration of tranexamic acid, and integration of point-of-care tests to support the guided substitution of coagulation factors, alongside standard laboratory tests. Additionally, cell salvage has proven beneficial and should be considered for various indications in obstetrics including hematologic disturbances, as well as various forms of placental disorders. Key Message: This article reviews PBM in pregnancy, delivery, and the puerperium. The concept comprises early screening and treatment of anemia and iron deficiency, a transfusion and coagulation algorithm during delivery, as well as cell salvage.

01 Jan 2021·American Journal of NephrologyQ3 · MEDICINE

Factors Affecting Doses of Roxadustat Versus Darbepoetin Alfa for Anemia in Nondialysis Patients

Q3 · MEDICINE

Article

Author: Tanaka-Amino, Keiko ; Akizawa, Tadao ; Yamaguchi, Yusuke ; Otsuka, Tetsuro

Introduction: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia of chronic kidney disease (CKD). This post hoc analysis of a Japanese, open-label, partially randomized, phase 3 study in nondialysis-dependent (NDD) CKD patients treated with traditional erythropoiesis-stimulating agents (ESAs) evaluated dosing trends of roxadustat and darbepoetin alfa (DA) required to maintain target hemoglobin concentrations in patients with risk factors associated with ESA hyporesponsiveness. Methods: Patients enrolled in the 1517-CL-0310 study (NCT02988973) that demonstrated noninferiority of roxadustat to DA for change in average hemoglobin levels of week 18–24 from baseline who had used human recombinant erythropoietin or DA before conversion and who were randomized to either roxadustat or DA were included. The endpoints were the average allocated dose of roxadustat and DA per administration in the last 6 weeks (AAD/6W), assessed by subgroups known to be associated with ESA hyporesponsiveness. The analysis of variance was performed by the treatment group to test the influence of subgroup factors on the AAD/6W of study drug. The ratios between the mean AAD/6W in each subgroup category and the within-arm mean AAD/6W were calculated. Results: Two hundred and sixty-two patients were randomized to either the roxadustat or DA comparative group and received treatment (roxadustat, n = 131; DA, n = 131). Higher mean (standard deviation) doses of both roxadustat (63.15 [24.84] mg) and DA (47.33 [29.79] μg) were required in the highest ESA resistance index (≥6.8) quartile (p = 0.003 and p < 0.001, respectively). Patients with adequate iron repletion had the lowest doses for both roxadustat (45.54 [18.01] mg) and DA (28.13 [20.98] μg). High-sensitivity C-reactive protein ≥28.57 nmol/L and the estimated glomerular filtration rate <15 mL/min/1.73 m2 were associated with requiring higher DA but not roxadustat doses. Discussion/Conclusion: The roxadustat dose required to maintain target hemoglobin in NDD patients in Japan with anemia of CKD relative to DA dose may not be impacted by low-grade inflammation. Roxadustat may be beneficial for ESA-hyporesponsive NDD CKD patients.

22 May 2020·Parkinson's DiseaseQ4 · MEDICINE

Flanker Task-Elicited Event-Related Potential Sources Reflect Human Recombinant Erythropoietin Differential Effects on Parkinson’s Patients

Q4 · MEDICINE

ArticleOA

Author: Galan Garcia, Lidice ; Bringas Vega, Maria L. ; Liu, Shengnan ; Jahanshahi, Marjan ; Zhang, Min ; Perez Bocourt, Vanessa ; Valdes-Sosa, Pedro A. ; Morales Chacon, Lilia M. ; Pedroso Ibañez, Ivonne

We used EEG source analysis to identify which cortical areas were involved in the automatic and controlled processes of inhibitory control on a flanker task and compared the potential efficacy of recombinant-human erythropoietin (rHuEPO) on the performance of Parkinson’s Disease patients. The samples were 18 medicated PD patients (nine of them received rHuEPO in addition to their usual anti-PD medication through random allocation and the other nine patients were on their regular anti-PD medication only) and 9 age and education-matched healthy controls (HCs) who completed the flanker task with simultaneous EEG recordings. N1 and N2 event-related potential (ERP) components were identified and a low resolution tomography (LORETA) inverse solution was employed to localize the neural generators. Reaction times and errors were increased for the incongruent flankers for PD patients compared to controls. EEG source analysis identified an effect of rHuEPO on the lingual gyri for the early N1 component. N2-related sources in middle cingulate and precuneus were associated with the inhibition of automatic responses evoked by incongruent stimuli differentiated PD and HCs. From our results rHuEPO seems to mediate an effect on N1 sources in lingual gyri but not on behavioural performance. N2-related sources in middle cingulate and precuneus were evoked by incongruent stimuli differentiated PD and HCs.

100 Deals associated with Recombinant erythropoietin biosimilar(Elea Spa)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	AR	Elea Spa	01 Jan 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02251041 (CAPITL, CTgov)	Phase 2	Reperfusion Injury	143	C1-Inhibitor+Epoprostenol+Infliximab+Melatonin+Alfa-tocopherol+Human recombinant erythropoietin+Glutathione	vfabznwitu(kqwyposzui) = bpzxtchmhx pfqytzchvf (vpzanxahnf, lnlanamari - fhatosyaoz) View more	-	23 Aug 2024