Delving into the Latest Updates on Recombinant human erythropoietin(Center of Molecular Immunology) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Epoetin alfa, NeuroEPO, NeuroEPO (nasal)

+ [3]

Target

EPO receptor

Action

agonists

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Hemic and Lymphatic DiseasesOther Diseases

Active Indication

Anemia, Aplastic

Inactive Indication-

Originator Organization

Center For Molecular Immunology

Active Organization

Center For Molecular Immunology

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Cuba (01 Apr 1998),

Anemia, Aplastic

Regulation-

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Structure/Sequence

Sequence Code 9003

The sequence is quoted from: *****

Author: Pillay, Shakti ; Masemola, Mogomane Yvonne Khomotso ; Nakwa, Firdose Lambey ; Babbo, Carina Corte-Real ; Velaphi, Sithembiso Christopher ; Coetzee, Melantha ; Pepper, Michael Sean ; Horn, Alan Richard ; van Rensburg, Jeanne ; Mellet, Juanita ; Ballot, Daynia Elizabeth ; Kali, Gugulabatembunamahlubi Tenjiwe Jabulile

AbstractBackgroundNeonatal encephalopathy (NE) due to suspected hypoxic-ischemic encephalopathy (HIE), referred to as NESHIE, is a clinical diagnosis in late preterm and term newborns. It occurs as a result of impaired cerebral blood flow and oxygen delivery during the peripartum period and is used until other causes of NE have been discounted and HIE is confirmed. Therapeutic hypothermia (TH) is the only evidence-based and clinically approved treatment modality for HIE. However, the limited efficacy and uncertain benefits of TH in some low- to middle-income countries (LMICs) and the associated need for intensive monitoring have prompted investigations into more accessible and effective stand-alone or additive treatment options.Data sourcesThis review describes the rationale and current evidence for alternative treatments in the context of the pathophysiology of HIE based on literatures from Pubmed and other online sources of published data.ResultsThe underlining mechanisms of neurotoxic effect, current clinically approved treatment, various categories of emerging treatments and clinical trials for NE are summarized in this review. Melatonin, caffeine citrate, autologous cord blood stem cells, Epoetin alfa and Allopurinal are being tested as potential neuroprotective agents currently.ConclusionThis review describes the rationale and current evidence for alternative treatments in the context of the pathophysiology of HIE. Neuroprotective agents are currently only being investigated in high- and middle-income settings. Results from these trials will need to be interpreted and validated in LMIC settings. The focus of future research should therefore be on the development of inexpensive, accessible monotherapies and should include LMICs, where the highest burden of NESHIE exists.Graphical abstract

27 Oct 2024·Cureus

Efficacy of Epoetin Alfa in Managing Symptomatic Anaemia in Low-Risk Myelodysplastic Syndromes: A Retrospective Analysis

Article

Author: Aboulela, Mohamed ; Collins, Angela

Background Myelodysplastic syndromes (MDS) are clonal myeloid disorders characterised by ineffective haematopoiesis, leading to anaemia that often requires dependence on red blood cell (RBC) transfusions. Epoetin alfa (Eprex®) is now a mainstay in the management of symptomatic anaemia in low-risk MDS patients, reducing transfusion dependence and improving the quality of life in this patient group. Objective This retrospective study aimed to assess the efficacy of epoetin alfa in treating symptomatic anaemia in low-risk MDS patients, focusing on transfusion independence and its relationship with baseline erythropoietin (EPO) levels and haemoglobin (Hb) response. Methods Data from 56 patients with low-risk MDS treated with epoetin alfa at Norfolk and Norwich University Hospital, Norwich, United Kingdom, between 2018 and 2023 were retrospectively analysed. Baseline EPO levels, transfusion history, Hb response, and the duration of transfusion independence were assessed. Statistical analyses were performed to evaluate the correlation between baseline characteristics and treatment outcomes. Results Among the patients, 98.2% had baseline EPO levels below the 500 IU/L threshold, with a median EPO level of 74.3 IU/L. Following an eight-week trial of 30,000 units of epoetin-alfa, 41.1% of patients showed improved Hb levels, 41.1% maintained stable Hb levels, and 17.9% experienced a decline. A significant correlation was found between lower baseline EPO levels (<250 IU/L) and a positive treatment response (p = 0.0065). Additionally, patients who required fewer transfusions before treatment had longer durations of transfusion independence (correlation coefficient = -0.40, p = 0.015). Dose escalation to 60,000 units provided a benefit to 53.3% of patients with initially stable Hb levels. The average duration of transfusion independence was 8.1 months, and patients with improved Hb levels had the longest periods of transfusion independence (p = 0.005). Conclusion Epoetin alfa is an effective therapy for managing symptomatic anaemia in low-risk MDS patients. This study highlights its efficacy and provides valuable predictive information, particularly showing that patients with lower baseline EPO levels are more likely to respond to treatment. While prior transfusion dependence did not significantly predict response to therapy in this cohort, it was associated with the duration of transfusion independence.

01 Jun 2024·Journal of Surgical Oncology

Oncoplastic reconstruction with breast‐conserving treatment versus breast‐conserving treatment alone in the elderly

Article

Author: Toncred, Styblo ; Faulkner, Heather R ; Lara, Schwieger ; Ambika, Menon ; Albert, Losken

AbstractBackground/ObjectivesOncoplastic reconstruction (IOR) performed in conjunction with breast conserving therapy (BCT) has been found to improve psychosocial well‐being, reduce hospitalization time, and reduce cost burden. Few studies have looked at the safety profile, complication rates, and overall outcomes in patients ages 65 years and older undergoing IOR versus BCT alone.MethodsA retrospective, cross‐sectional, single‐institution medical record review was conducted of women diagnosed with breast cancer age 65 years or older who received IOR or BCT alone. Demographics, clinical data, and major and minor complication profiles were compared between cohorts.ResultsA total of 310 patients were included. Of these, 126 received IOR, while 184 received BCT alone. Age >85 was found to have a significantly higher risk for any complication and was an independent predictor for experiencing any complication (OR: 8.5, p = 0.015; OR: 1.06, p = 0.029). Major complication rates were significantly higher in the BCT cohort (16.9% vs. 7.9%, p = 0.023).ConclusionIOR in the elderly is a safe option and was not found to be a predictor of experiencing higher complications. Patients who are 85 years and older had a higher risk of complications, and future studies may explore risk‐benefit in that particular cohort of patients in which BCT is planned.

100 Deals associated with Recombinant human erythropoietin(Center of Molecular Immunology)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	DB00016

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia, Aplastic	Cuba	Center For Molecular Immunology	01 Apr 1998

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


COMMANDS Trial (ASH2023)	Not Applicable	Myelodysplastic Syndromes	-	Luspatercept	(gmkhunrqzy) = axyovwvmvc wfutbqzzwk (udbbttutgi, 108.3 - NE)	Positive	09 Dec 2023
				Epoetin alfa	(gmkhunrqzy) = qlmuvsodbh wfutbqzzwk (udbbttutgi, 5.9 - 157.3)
AAIC2021	Not Applicable	Alzheimer Disease	174	NeuroEPO 0.5 mg	-	Positive	31 Dec 2021
				NeuroEPO 1.0 mg
ASN2020	Phase 3	Anemia \| Heart Failure	-	Roxadustat	wgywlyhavx(odiwunykho): 0.73 (95% CI, 0.58 - 0.94), P-Value = 0.013	Positive	19 Oct 2020
				Epoetin alfa
DD-CKD (ASN2020)	Not Applicable	Chronic Kidney Diseases Hemoglobin \| transferrin \| serum iron ... View more	3,890	Roxadustat	bkbmwtrjsl(zxkfrknlcg) = bpgxfwlnsl xxtujhkedu (buozdxzzqo ) View more	Positive	19 Oct 2020
				Epoetin alfa	bkbmwtrjsl(zxkfrknlcg) = ztdlqpmugs xxtujhkedu (buozdxzzqo ) View more
ASN2020	Phase 3	Anemia in chronic kidney disease	-	Roxadustat	(rgfykbxpus) = hgupjccjmr izbqkdmsuu (zqkqvrwwrm )	Positive	19 Oct 2020
				Placebo	(rgfykbxpus) = xqdqfdlsga izbqkdmsuu (zqkqvrwwrm )
ASN2019	Not Applicable	Drug Hypersensitivity Syndrome	-	Epoetin alfa	(lwdshqhskd) = Dermatology biopsied a lesion & recommended methylprednisolone (MP) IV for 2 days. Rash, eosinophils & creatinine improved. MP was discontinued as per derm. recc. but rash, eosinophils & creatinine again worsened. Biopsy: spongiotic dermatitis w/parakeratosis, pustules in stratum corneum, dermal perivascular lymphocytic infiltrate & scanty eosinophils. Allergist recc. restart MP for epoetin alfa related DRESS. See Fig 1 for data on MP, creatinine & eosinophils. He improved & was discharged on a steroid tapering. khyzhgygnd (eqhkmkabae ) View more	-	05 Nov 2019
ASN2012	Not Applicable	-	-	Epoetin alfa	mhamylezgn(ziticbhhqd) = anocjgsjsi vyqfkfemil (pbujlnksow )	-	30 Oct 2012
				Intravenous Iron	qyionthsee(exazqrynwr) = gpjexaffxj huiyigdxyu (arcihwjrsw ) View more
ASN2010	Not Applicable	IL-18 \| NGAL	72	Epoetin alfa	ppksuibahc(lmckksrhou) = 7 in the epoetin group compared to 6 in the saline group sxivnsigyv (mhethvxnsa ) View more	Negative	16 Nov 2010
				Saline
ASN2010	Not Applicable	Maintenance	128	Epoetin alfa	hlqsmcuywy(hvyjvgsiyg) = povjlmjeuu mqctwfbxoj (trynnmivtq, 15086.55 - 46875) View more	Negative	16 Nov 2010
				Epoetin beta	hlqsmcuywy(hvyjvgsiyg) = wgrdkpajwp mqctwfbxoj (trynnmivtq, 12549.12 - 33389.63) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Recombinant human erythropoietin(Center of Molecular Immunology)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation