Epogen (epoetin alfa) News

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||||||||||  Epogen (epoetin alfa) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Adverse events:  PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns (clinicaltrials.gov) -  Apr 28, 2021
P3, N=313, Active, not recruiting,  Sponsor: University of Sydney
Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Mar 2023 | Trial primary completion date: Dec 2021 --> Mar 2023

|||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin
[VIRTUAL] THE BURDEN OF HEART FAILURE IN PATIENTS WITH NON–DIALYSIS-DEPENDENT ANAEMIA OF CHRONIC KIDNEY DISEASE RECEIVING ERYTHROPOIESIS-STIMULATING AGENTS: A SYSTEMATIC LITERATURE REVIEW () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_860;
We observed substantial heterogeneity in the reporting and results of HF-related outcomes in ESA RCTs. Information from observational studies may also be needed to fully characterise the burden of HF in patients with NDD-CKD and anaemia on ESA treatment.

|||||||||| Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin
[VIRTUAL] TREATMENT BURDEN AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH NON–DIALYSIS-DEPENDENT ANAEMIA OF CHRONIC KIDNEY DISEASE RECEIVING ERYTHROPOIESIS-STIMULATING AGENTS: A SYSTEMATIC LITERATURE REVIEW () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_859;
Questionnaire use was low; SF-36 was mostly frequently used, which is not specific to kidney disease/anemia of CKD. More consideration and consistency of patient-centric outcomes, including complementary evidence from observational studies, may help better understand the holistic impact of ESA treatment on clinical management.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] CARDIOVASCULAR OUTCOMES AND EXPLORATORY ANALYSES BY ACHIEVED HB LEVELS IN POOLED PHASE 3 TRIALS OF ROXADUSTAT IN DIALYSIS-DEPENDENT PATIENTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_856;
In roxadustat-treated patients, MACE and MACE+ incidence rates were lowest when achieved Hb levels were ≥10 g/dL. This abstract was in part submitted for the American Society of Nephrology 2020 Congress.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] HEMOGLOBIN (HB) CORRECTION WITH ROXADUSTAT IS ASSOCIATED WITH IMPROVED IRON HOMEOSTASIS IN PATIENTS WITH NON-DIALYSIS-DEPENDENT (NDD) AND DIALYSIS-DEPENDENT (DD) CHRONIC KIDNEY DISEASE (CKD) () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_855;
Conclusions In both patients with NDD-CKD and DD-CKD, roxadustat facilitated iron transport and utilization resulting in increases in both serum iron and TIBC, likely driven by reduced hepcidin. Overall, despite the observed greater Hb increase from BL with roxadustat, IV iron use was reduced with roxadustat in both the NDD-CKD and DD-CKD populations.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] ROXADUSTAT INCREASES HEMOGLOBIN IN ANEMIC NON-DIALYSIS-DEPENDENT (NDD) AND DIALYSIS-DEPENDENT (DD) CHRONIC KIDNEY DISEASE (CKD) PATIENTS INDEPENDENT OF INFLAMMATION () - Apr 17, 2021 - Abstract #ISNWCN2021ISN-WCN_828;
In patients with DD-CKD patients, roxadustat dosing at Week 24 did not increase in patients with and without inflammation, whereas higher doses of epoetin alfa were required in patients with hsCRP >13.56 mg/L. No unexpected safety issues were observed in either population.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Congestive Heart Failure Inpatient Costs in Chronic Kidney Disease and Event Rates in Roxadustat Global Phase 3 Program () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1228;
In the DD CKD study population, fewer patients on roxadustat were hospitalized due to CHF compared to patients on epoetin alfa (HR=0.73; 95% CI: 0.58, 0.94). CONCLUSIONS Treatment with roxadustat for anemia of CKD may mitigate CHF hospitalization rates and decrease associated healthcare costs.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Major Adverse Cardiovascular Event Inpatient Costs in Dialysis Dependent Chronic Kidney Disease and Event Rates in Roxadustat Global Phase 3 Program () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1227;
In the DD CKD study population, MACE rates in the roxadustat arm were non-inferior to epoetin alfa (HR=0.96; 95% CI: 0.82, 1.13) and lower for MACE-plus (HR=0.86; 95% CI: 0.74, 0.98). CONCLUSIONS : Anemia management in CKD may reduce cardiovascular event rates and subsequently lower associated costs and healthcare resource utilization.

|||||||||| Epogen (epoetin alfa) / Amgen, Revlimid (lenalidomide) / BMS
Monotherapy: Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin [Jan 13, 2021] List, Sun, et al. JCO @ASCO_pubs https://t.co/6KozbfJ6Nd #EAonc E2905 #NCT02048813 #MDSsm HT @SCTNB (Twitter) - Apr 9, 2021
P3

|||||||||| Epogen (epoetin alfa) / Amgen
Clinical: Ha! “analyses do not change the Company’s assessment that roxa is comparable to placebo in non-dialysis dependent PTs and to epoetin-alfa in dialysis dependent PTs using MACE to measure cardiovascular safety”... but advantage of roxa in terms of MACE+ is lost in.. (Twitter) - Apr 7, 2021

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Retrospective data, Review, Journal: Roxadustat (FG-4592) Treatment for Anemia in dialysis-dependent (DD) and not dialysis-dependent (NDD) chronic kidney disease patients: A Systematic review and meta-analysis. (Pubmed Central) - Mar 30, 2021
This review found roxadustast increases the levels of hemoglobin, serum transferrin, intestinal iron absorption, and reduces hepcidin in both NDD and DD-CKD patients. Safety data is still emerging.

|||||||||| Epogen (epoetin alfa) / Amgen, Revlimid (lenalidomide) / BMS
Lower-risk, non-del(5q) MDS with anemia insensitive to growth factors may derive benefit from combination Lenalidomide + Epoetin Alfa via ⁦@ASCO_pubs⁩ ⁦@Amitvermamds⁩ 👇👇 https://t.co/fAmLxph9dy (Twitter) - Mar 24, 2021

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] ENHANCED DEGRADATION OF 3-HYDROXY-3-METHYLGLUTARYL COENZYME A REDUCTASE (HMGCR) MAY CONTRIBUTE TO THE LOWERING OF LDL CHOLESTEROL SEEN WITH ROXADUSTAT IN PATIENTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE (Hall London) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_1341;
Safety data is still emerging. These data show that treatment with roxadustat vs. placebo or epoetin alfa lowered LDL-C in patients with NDD-CKD and DD-CKD, respectively, and highlight a potential HIF-dependent mechanism for this cholesterol-lowering effect.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Retrospective data, Journal: Pooled Analysis of Roxadustat for Anemia in Patients With Kidney Failure Incident to Dialysis. (Pubmed Central) - Mar 19, 2021
Roxadustat was at least as efficacious as epoetin alfa. Roxadustat had a lower risk of MACE/MACE+ in patients new to dialysis.

||||||||||  Epogen (epoetin alfa) / Amgen
Trial completion:  CD71 in Dried Blood Spots in Healthy Males (clinicaltrials.gov) -  Mar 17, 2021
P1, N=24, Completed,  Sponsor: Sports Medicine Research and Testing Laboratory
Roxadustat had a lower risk of MACE/MACE+ in patients new to dialysis. Enrolling by invitation --> Completed

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
Clinical: Presented by @sfishbane at #ASH20: In patients with anemia and dialysis-dependent chronic kidney disease, treatment with roxadustat led to higher hemoglobin levels and a reduced need for transfusions, compared with treatment with epoetin alfa https://t.co/wPqXjjlVAk (Twitter) - Mar 10, 2021

||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial completion date, Trial primary completion date:  COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Na (clinicaltrials.gov) -  Mar 9, 2021
P3, N=350, Recruiting,  Sponsor: Celgene
Enrolling by invitation --> Completed Trial completion date: Nov 2022 --> Jun 2022 | Trial primary completion date: Nov 2022 --> Jun 2022

|||||||||| Epogen (epoetin alfa) / Amgen
Clinical: Epogen for anemia in CKD, then expanded for chemotherapy and HIV patients (Twitter) - Mar 4, 2021

|||||||||| Epogen (epoetin alfa) / Amgen
[VIRTUAL] Success of Online CME at Improving Nephrologist Understanding of an Emerging Class of Drugs to Treat CKD-Anemia () - Mar 2, 2021 - Abstract #NKFSCM2021NKF-SCM_740;
Overall improvements were seen after participation in both CME activities: 15% of nephrologists demonstrated improvements at recognizing clinical trial data comparing HIF-PHIs to epoetin alfa in patients with dialysis-dependent CKD (P=.06) 34% of nephrologists demonstrated improvements at identifying safety issues addressed with the FDA black box warning on erythropoiesis-stimulating agents (ESAs) (P<.01) 42% of nephrologists demonstrated improvements at recognizing prevalence of ESA-hyporesponsiveness (P<.01) 56% reported increased confidence in knowledge of HIF-PHIs in the treatment of anemia in patients with CKD on dialysis Continued educational gaps: 32% of nephrologists did not recognize the clinical differences in HIF PHIs and epoetin alfa 28% of nephrologists did not recognize a safety issue of ESAs 25% of nephrologists did not recognize the prevalence of ESA hyporesponsiveness CONCLUSION This study demonstrates the success of online, video-based roundtable discussion on improving knowledge of nephrologists related to HIF-PHIs for the treatment of anemia associated with dialysis dependent CKD. Continued knowledge gaps were identified for future educational targets.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Risk of RBC Transfusion and Volume-Related Adverse Events in Patients with Non–dialysis-dependent Chronic Kidney Disease: Pooled Results from Roxadustat Phase 3 Studies () - Mar 2, 2021 - Abstract #NKFSCM2021NKF-SCM_723;
CONCLUSION Roxadustat reduced the risk of RBC transfusion vs. placebo in patients with NDD-CKD. In US patients, risk of transfusion was lowest at achieved Hb ≥10 gm/dL, and globally, volume-related AE rates were higher in the 2-week post-transfusion period.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Risk of RBC Transfusion and Volume-Related Adverse Events in Patients with Dialysis-dependent Chronic Kidney Disease: Pooled Results from Roxadustat Phase 3 Studies () - Mar 2, 2021 - Abstract #NKFSCM2021NKF-SCM_722;
CONCLUSION Roxadustat reduced risk of RBC transfusion vs. epoetin alfa in patients with DD-CKD. In US patients, risk of transfusion was lowest at achieved Hb ≥10 gm/dL, and globally, volume-related AE rates were higher in the 2-week post-transfusion period.

|||||||||| Epogen (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Roxadustat Efficacy in Non-Dialysis-Dependent Through Dialysis-Dependent Chronic Kidney Disease () - Mar 2, 2021 - Abstract #NKFSCM2021NKF-SCM_568;
The roxadustat group exhibited lower mean (SD) IV iron use than the epoetin alfa group (52.2 [226.3] vs. 66.8 [162.1] mg/PEM), and less need for RBC transfusion during treatment (9.5% vs. 12.8%; HR=0.82 [95% CI: 0.679, 0.997; p=0.046]). CONCLUSION The efficacy of roxadustat vs. placebo/epoetin alfa for improving Hb level and reducing rescue therapy/IV iron use was demonstrated across the NDD, ID-DD, and DD stages of CKD progression.

|||||||||| Epogen (epoetin alfa) / Amgen
That's a great question! I guess I typically write "epoetin alfa"... so I have not thought about the difference involving the "i". (Twitter) - Feb 16, 2021

|||||||||| Epogen (epoetin alfa) / Amgen
But g5 and even G6 is ok says government hyprocrit's . (Twitter) - Feb 15, 2021

||||||||||  Oxemia (desidustat) / Zydus Lifesci
Trial primary completion date:  DREAM-D: Desidustat in the Treatment of Anemia in CKD on Dialysis Patients (clinicaltrials.gov) -  Jan 27, 2021
P3, N=392, Recruiting,  Sponsor: Cadila Healthcare Limited
CONCLUSION The efficacy of roxadustat vs. placebo/epoetin alfa for improving Hb level and reducing rescue therapy/IV iron use was demonstrated across the NDD, ID-DD, and DD stages of CKD progression. Trial primary completion date: May 2021 --> Aug 2021

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
Clinical, Retrospective data, Journal, HEOR: Cost-minimization analysis between intravenous iron sucrose and iron sucrose similar in hemodialysis patients. (Pubmed Central) - Jan 23, 2021
Trial primary completion date: May 2021 --> Aug 2021 This cost minimization analysis suggests that for chronic hemodialysis patients, iron sucrose and iron sucrose similar have the same efficacy and that using iron sucrose similar was more expensive in 66.7% of iterations.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Revlimid (lenalidomide) / BMS
Monotherapy: 1) So this paper by Alan List, @MartinTallman @jaltmanmd @Ramikomrokji @Amitvermamds and others is finally out-Lenalidomide-Epoetin Alfa Versus Lenalidomide Monotherapy in Myelodysplastic Syndromes Refractory to Recombinant Erythropoietin https://t.co/xFPUack5bO (Twitter) - Jan 18, 2021

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin, Retacrit (epoetin alfa biosimilar) / Stada, Norbitec, Pfizer
[VIRTUAL] Pharmacy driven conversion of darbepoetin to epoetin alfa-epbx in an outpatient hemodialysis clinic: an evaluation of potential costs and outcomes () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4976;
Key secondary endpoints will include mean changes of ESA dosing per month, mean weekly cost of ESA therapy, and incidence of blood transfusions. Patients will retrospectively be reviewed five months before Retacrit implementation and will be continued to be reviewed for five months following implementation.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Retacrit (epoetin alfa biosimilar) / Stada, Norbitec, Pfizer
[VIRTUAL] Evaluating use, conversion eligibility, and cost of epoetin alfa-epbx once-weekly conversion to three times weekly. () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3831;
The goal sample size for this study is 100 patients. Descriptive statistics will be presented for data collected.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, DexIron (iron dextran) / Daiichi Sankyo
[VIRTUAL] Comparison of the efficacy, adverse events, and costs of using a novel dosing strategy of sodium ferric gluconate complex (SFGC) vs. iron dextran (ID) () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3732;
Inclusion criteria consists of the presence of an iron infusion consult placed to the pharmacy services department. Patients were excluded if they had at least one of the following criteria: chronic kidney disease, received epoetin alfa, pregnancy, actively receiving chemotherapy, less than 18 years old, and patients who did not receive either the 250mg or 500mg dose of SFG in the SFG group.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
[VIRTUAL] Medication use evaluation of erythropoietin stimulating agent in end-stage renal disease () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3403;
However, some situations require clinical judgment as Retacrit dosing is based on patient specific clinical circumstances. The majority of the Retacrit usage is monitored by Nephrologists and their associates.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
[VIRTUAL] Fatal outcome of pulmonary embolism in a non-critically ill COVID-19 patient on erythropoiesis-stimulating agent (ESA): a case report () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3301;
Remdesivir was not initiated due to the patient meeting exclusion criteria per institutional protocol of creatinine clearance < 30 mL/min...Outpatient dosing of epoetin alfa-epbx (Retacrit) 10,000 units (128 units/kg) three times weekly was continued inpatient...If an ESA is to be utilized in COVID-19 positive dialysis population, considering a more conservative Hgb goal might be appropriate and closer monitoring is warranted. Further randomized controlled studies are also much needed to shed light onto optimal thromboprophylaxis for non-critical care population.References available upon request

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
[VIRTUAL] Epoetin alfa utilization at Palos Hospital () - Dec 26, 2020 - Abstract #ASHP2020ASHP_1934;
Eleven patients (11%) received epoetin alfa outside of hemoglobin parameters. Epoetin alfa utilizes iron stores yet < 50% of patients had iron levels available during the admission; it is unknown if iron levels were completed at an outside institution.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
Journal: A conspectus of Neotropical Lauxaniidae (Diptera: Lauxanioidea). (Pubmed Central) - Dec 21, 2020
The following 96 lauxaniid species-group names are in new combinations: Allominettia approximata (Malloch, 1928; Deutominettia Hendel, 1925), Allominettia assimilis (Malloch, 1926; Minettia Robineau-Desvoidy, 1830), Allominettia rubescens (Macquart, 1844b; Sapromyza Fallén, 1810), Allominettia woldae (Broadhead, 1989; Homoeominettia Broadhead, 1989), Camptoprosopella sigma (Hendel, 1910; Procrita Hendel, 1908), Camptoprosopella verena (Becker, 1919; Sapromyza Fallén, 1810), Dryosapromyza pirioni (Malloch, 1933; Minettia Robineau-Desvoidy, 1830), Elipolambda duodecimvittata (Frey, 1919; Lauxania Latreille, 1804), Elipolambda lopesi (Shewell, 1989; Sapromyza Fallén, 1810), Elipolambda picrula (Williston, 1897; Sapromyza Fallén, 1810), Griphoneuromima frontalis (Macquart, 1844b; Sapromyza Fallén, 1810), Homoneura maculipennis (Loew, 1847; Sapromyza Fallén, 1810), Lauxanostegana albispina (Albuquerque, 1959; Steganopsis Meijere 1910), Marmarodeceia claripennis (Curran, 1934a; Pseudogriphoneura Hendel, 1907), Melanomyza nigerrima (Becker, 1919; Sapromyza Fallén, 1810), Meraina ferdinandi (Frey, 1919; Lauxania Latreille, 1804), Minettia altera (Curran, 1942; Pseudogriphoneura Hendel, 1907), Minettia duplicata (Lynch Arribálzaga, 1893; Sapromyza Fallén, 1810), Minettia lateritia (Rondani, 1863; Sapromyza Fallén, 1810), Minettia lupulinoides (Williston, 1897; Sapromyza Fallén, 1810), Minettia pallens (Blanchard, 1854; Sapromyza Fallén, 1810), Minettia remota (Thomson, 1869; Sapromyza Fallén, 1810), Minettia setosa (Thomson, 1869; Sapromyza Fallén, 1810), Myzaprosa chiloensis (Malloch, 1933; Sapromyza Fallén, 1810), Myzaprosa emmesa (Malloch, 1933; Sapromyza Fallén, 1810), Myzaprosa triloba (Malloch, 1933; Sapromyza Fallén, 1810), Neodecia albovittata (Loew, 1862; Lauxania Latreille, 1804), Neodecia bivittata (Curran, 1928b; Pseudogriphoneura Hendel, 1907), Neodecia flavipennis (Curran, 1928b; Pseudogriphoneura Hendel, 1907), Neodecia vittifacies (Curran, 1931; Pseudogriphoneura Hendel, 1907), Neominettia eronis (Curran, 1934a; Sapromyza Fallén, 1810), Neominettia lebasii (Macquart, 1844b; Sapromyza Fallén, 1810), Neominettia melanaspis (Wiedemann, 1830; Sciomyza Fallén, 1820d), Neoxangelina congruens (Hendel, 1910; Physegenua Macquart, 1848a/b), Neoxangelina facialis (Wiedemann, 1830; Sciomyza Fallén, 1820d), Neoxangelina flavipes (Hendel, 1926; Physegenua Macquart, 1848a/b), Paracestrotus albipes (Fabricius, 1805; Scatophaga Fabricius, 1805), Paradeceia incidens (Curran, 1934a; Sapromyza Fallén, 1810), Paradeceia shannoni (Malloch, 1933; Sapromyza Fallén, 1810), Paradeceia sororia (Williston, 1896b; Sapromyza Fallén, 1810), Physegenua annulata (Macquart, 1844b; Ephydra Fallén, 1810), Physoclypeus nigropleura (Papp Silva, 1995; Paraphysoclypeus Papp Silva, 1995), Poecilohetaerus suavis (Loew, 1847; Sapromyza Fallén, 1810), Poecilolycia blanchardi (Malloch, 1933; Sapromyza Fallén, 1810), Poecilolycia lineatocollis (Blanchard, 1854; Sapromyza Fallén, 1810), Poecilominettia aibonito (Curran, 1926; Minettia Robineau-Desvoidy, 1830), Poecilominettia bipunctata (Say, 1829; Sapromyza Fallén, 1810), Poecilominettia evittata (Malloch, 1926; Minettia Robineau-Desvoidy, 1830), Poecilominettia mona (Curran, 1926; Minettia Robineau-Desvoidy, 1830), Poecilominettia nigropunctata (Malloch, 1928; Minettia Robineau-Desvoidy, 1830), Poecilominettia plantaris (Thomson, 1869; Sapromyza Fallén, 1810), Poecilominettia quichuana (Brèthes, 1922; Sapromyza Fallén, 1810), Poecilominettia schwarzi (Malloch, 1928; Sapromyza Fallén, 1810), Poecilominettia sonax (Giglio-Tos, 1893; Sapromyza Fallén, 1810), Poecilominettia thomsonii (Lynch-Arribálzaga, 1893; Sapromyza Fallén, 1810), Poecilominettia triseriata (Coquillett, 1904a; Sapromyza Fallén, 1810), Pseudocalliope albomarginata (Malloch, 1933; Minettia Robineau-Desvoidy, 1830), Pseudodeceia leptoptera (Frey, 1919; Lauxania Latreille, 1804), Pseudogriphoneura albipes (Wiedemann, 1830; Lauxania Latreille, 1804), Pseudominettia argyrostoma (Wiedemann, 1830; Lauxania Latreille, 1804), Ritaemyia unifasciata (Macquart, 1835; Tephritis Latreille, 1804), Sciosapromyza fuscinervis (Malloch, 1926; Minettia Robineau-Desvoidy, 1830), Sciosapromyza limbinerva (Rondani, 1848; Sapromyza Fallén, 1810), Sciosapromyza scropharia (Fabricius, 1805; Scatophaga Fabricius, 1805), Scutominettia guyanensis (Macquart, 1844b; Sapromyza Fallén, 1810), Sericominettia argentiventris (Malloch, 1928; Minettia Robineau-Desvoidy, 1830), Sericominettia aries (Curran, 1942; Pseudogriphoneura Hendel, 1907), Sericominettia holosericea (Fabricius, 1805; Scatophaga Fabricius, 1805), Sericominettia nigra (Curran, 1934a; Pseudogriphoneura Hendel, 1907), Sericominettia velutina (Walker, 1853; Helomyza Fallén, 1820a), Stenolauxania flava (Silva, 1999a; Bacilloflagellomera Papp Silva, 1995), Stenolauxania fusca (Silva, 1999a; Bacilloflagellomera Papp Silva, 1995), Stenolauxania longicornus (Silva, 1999a; Bacilloflagellomera Papp Silva, 1995), Stenolauxania nigrifemuris (Silva, 1999a; Bacilloflagellomera Papp Silva, 1995), Stenolauxania pectinicornis (Papp Silva, 1995; Bacilloflagellomera Papp Silva, 1995), Trivialia nigrifrontata (Becker, 1919; Sapromyza Fallén, 1810), Trivialia scutellaris (Williston, 1896b; Phortica Schiner, 1862), Trivialia venusta (Williston, 1896b; Sapromyza Fallén, 1810), Xenochaetina annuliventris (Hendel, 1926; Allogriphoneura Hendel, 1925), Xenochaetina glabella (Becker, 1895; Lauxania Latreille, 1804), Xenochaetina nigra (Williston, 1896b; Physegenua Macquart, 1848a/b), Xenochaetina phacosoma (Hendel, 1926; Allogriphoneura Hendel, 1925), Xenochaetina porcaria (Fabricius, 1805; Scatophaga Fabricius, 1805), Xenochaetina robusta (Walker, 1858; Helomyza Fallén, 1820a), Zamyprosa dichroa (Malloch, 1933; Minettia Robineau-Desvoidy, 1830), Zamyprosa edwardsi (Malloch, 1933; Sapromyza Fallén, 1810), Zamyprosa ferruginea (Macquart, 1844b; Opomyza Fallén, 1820b), Zamyprosa fulvescens (Blanchard, 1854; Sciomyza Fallén, 1820d), Zamyprosa fulvicornis (Malloch, 1933; Sapromyza Fallén, 1810), Zamyprosa micropyga (Malloch, 1933; Sapromyza Fallén, 1810), Zamyprosa nigripes (Macquart, 1844b; Sapromyza Fallén, 1810), Zamyprosa nigriventris (Blanchard, 1854; Sapromyza Fallén, 1810), Zamyprosa parvula (Blanchard, 1854; Sapromyza Fallén, 1810), Zamyprosa semiatra (Malloch, 1933; Sapromyza Fallén, 1810), Zamyprosa seminigra (Malloch, 1933; Minettia Robineau-Desvoidy, 1830), Zargopsinettia verticalis (Malloch, 1928; Minettia Robineau-Desvoidy, 1830)...The remaining species, Sapromyza fuscipes Macquart, 1844b, is of uncertain family placement within the Muscoidea. The following new replacement names for species of Platystomatidae were necessary due to homonymy: Senopterina gigliotosi Gaimari Silva (for Bricinniella cyanea Giglio-Tos, 1893, nec Lauxania cyanea Fabricius, 1805), and Rivellia macquarti Gaimari Silva (for Tephritis unifasciata Macquart, 1843: 381, nec Macquart, 1835: 465).

|||||||||| Mircera (methoxy polyethylene glycol-epoetin beta) / Roche, Vifor, Epogen, Procrit (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin
Clinical, Journal, Head-to-Head: Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. (Pubmed Central) - Dec 3, 2020
P4
The following new replacement names for species of Platystomatidae were necessary due to homonymy: Senopterina gigliotosi Gaimari Silva (for Bricinniella cyanea Giglio-Tos, 1893, nec Lauxania cyanea Fabricius, 1805), and Rivellia macquarti Gaimari Silva (for Tephritis unifasciata Macquart, 1843: 381, nec Macquart, 1835: 465). In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality.

||||||||||  Reblozyl (luspatercept-aamt) / BMS, Merck (MSD)
Trial primary completion date:  COMMANDS: A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Na (clinicaltrials.gov) -  Dec 2, 2020
P3, N=350, Recruiting,  Sponsor: Celgene
In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality. Trial primary completion date: Apr 2021 --> Nov 2022

||||||||||  Jesduvroq (daprodustat) / GSK, Kyowa Kirin
Trial completion, Enrollment change:  Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP) (clinicaltrials.gov) -  Nov 23, 2020
P2, N=100, Completed,  Sponsor: GlaxoSmithKline
Trial primary completion date: Apr 2021 --> Nov 2022 Recruiting --> Completed | N=62 --> 100

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin
Journal: Glycan analysis of erythropoiesis-stimulating agents. (Pubmed Central) - Nov 19, 2020
The products exhibit notable differences in N- and O-glycosylation, including attributes such as sialic acid occupation, O-acetylation, N-acetyllactosamine extended antennae and sulphated/penta-sialylated N-glycans, which have the potential to cause divergence of therapeutic potencies. The study highlights the need for continued monitoring of ESA product glycosylation, ideally allied to pharmacological data, in order to ensure consistency and therapeutic equivalence between products and enhance our understanding of ESA structure-activity-relationships.

||||||||||  Eprex (epoetin alfa) / J&J, Epogen (epoetin alfa) / Amgen, Binocrit (epoetin alfa biosimilar) / Medice, Sandoz
Enrollment open:  EPO-TRAUMA: ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients (clinicaltrials.gov) -  Nov 11, 2020
P3, N=2500, Recruiting,  Sponsor: Australian and New Zealand Intensive Care Research Centre
The study highlights the need for continued monitoring of ESA product glycosylation, ideally allied to pharmacological data, in order to ensure consistency and therapeutic equivalence between products and enhance our understanding of ESA structure-activity-relationships. Not yet recruiting --> Recruiting

||||||||||  Eprex (epoetin alfa) / J&J, Epogen (epoetin alfa) / Amgen
Trial completion date, Trial primary completion date:  EPO-PRETAR: A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (clinicaltrials.gov) -  Nov 8, 2020
P3, N=124, Recruiting,  Sponsor: Groupe Francophone des Myelodysplasies
Not yet recruiting --> Recruiting Trial completion date: Oct 2021 --> May 2024 | Trial primary completion date: Oct 2019 --> May 2022

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin
[VIRTUAL] An Observational Study to Collect and Assess Tissue Samples from Subjects with One of Three Neoplastic Conditions (ANSWer) () - Nov 5, 2020 - Abstract #ASH2020ASH_4998;
The correlation between clinical response and drug sensitivity will be assessed using the area under the receiver-operator curve (AUROC) and bootstrapping to test for significance. A generalized estimation equation model will be used to identify associations between additional exploratory biomarkers, such as somatic mutations identified via NGS, andex vivosensitivity to various drug classes within specific treatment cohorts.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Hakko Kirin, Reblozyl (luspatercept-aamt) / Acceleron, BMS
[VIRTUAL] The Commands Trial: A Phase 3 Study of the Efficacy and Safety of Luspatercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low-, Low-, or Intermediate-Risk MDS in Erythropoiesis Stimulating Agent-Naive Patients Who Require RBC Transfusions (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_2662;
P3
Recent studies of epoetin alfa and darbepoetin alfa have demonstrated efficacy among patients with LR-MDS, but the patient population in whom a clinically significant effect is seen may be limited (Fenaux P, et al...Exclusion criteria include prior use of ESAs (≤ 2 doses of prior epoetin alfa permitted if ≥ 8 weeks from randomization date and sEPO confirmed as ≤ 500 U/L), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF), unless given for the treatment of febrile neutropenia; disease-modifying agents (e.g. lenalidomide), or hypomethylating agents; and presence of del(5q) cytogenetic abnormality...Key secondary endpoints include duration of RBC-TI, change in Hb levels, achievement of HI-E response per International Working Group (IWG) 2006 criteria, and safety. The COMMANDS trial is registered at ClinicalTrials.gov (NCT03682536) and EudraCT (number 2017-003190-34).

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Pooled Efficacy and Cardiovascular Safety Results of Roxadustat Compared with Epoetin Alfa in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1703;
It also significantly reduced MACE risk in incident dialysis patients and MACE+ risk in both the all-dialysis patients and incident dialysis patients groups. Additionally, roxadustat reduced RBC transfusion compared with EPO in the all-dialysis pooled analysis.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Roxadustat Lowers Risk of RBC Transfusion in Patients with Anemia of CKD (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1702;
Roxadustat markedly and significantly reduced transfusion risk versus placebo in NDD CKD, and this effect was consistent across trials. Roxadustat also significantly reduced transfusion risk versus epoetin alfa in DD CKD in the pooled analysis, although this varied within trials.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen, Evrenzo (roxadustat) / Astellas, AstraZeneca, FibroGen
[VIRTUAL] Oral Roxadustat Demonstrates Efficacy in Anemia Secondary to Lower-Risk Myelodysplastic Syndrome Irrespective of Ring Sideroblasts and Baseline Erythropoietin Levels (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1063;
P3
The ongoing, 156-patient, double-blind study phase uses a 2.5 mg/kg starting dose. Preliminary data in OL subgroups RS-/RS + and BL EPO ≤ 200 mIU/ml and >200 mIU/ml suggest roxadustat may be effective in these subgroups.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
Clinical, Journal: Surgical prescription of epoetin alfa in contemporary total hip arthroplasty: a prospective comparative study. (Pubmed Central) - Oct 25, 2020
The amended protocol does not lead to increased peri-operative bleeding. Advances in intra-operative methods to reduce the bleeding allow changing indications of EPO in patients undergoing THA with a low level of Hb.

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
Epogen (Twitter) - Oct 24, 2020

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
Nepogen (Twitter) - Oct 24, 2020

|||||||||| Epogen, Procrit (epoetin alfa) / Amgen
Journal: Different Pollinators' Functional Traits Can Explain Pollen Load in Two Solitary Oil-Collecting Bees. (Pubmed Central) - Oct 21, 2020
For C. chilensis, it was only its body size that affected the Calceolaria pollen load, while in C. subcaeruleus, both body size and handling time together account for its pollen load. Overall, these results highlight the role of pollinators' functional traits in different stages of the pollination process, and even more in specialized plant-pollination systems.

||||||||||  Eprex (epoetin alfa) / J&J, Epogen (epoetin alfa) / Amgen, Binocrit (epoetin alfa biosimilar) / Medice, Sandoz
New P3 trial:  EPO-TRAUMA: ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients (clinicaltrials.gov) -  Oct 19, 2020
P3, N=2500, Not yet recruiting,  Sponsor: Australian and New Zealand Intensive Care Research Centre



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