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1149:
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1104:
975:"A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions"
619:(FDA) granted approval for luspatercept–aamt in November 2019, for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. Luspatercept was approved for medical use in the European Union in June 2020.
1096:
533:
for the treatment of adults with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
263:
1034:
953:"A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-Thalassemia"
218:
858:
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597:
Phase III trials evaluated the efficacy of luspatercept for the treatment of anemia in the hematological disorders beta thalassemia and myelodysplastic syndromes.
545:
Possible adverse effects include temporary bone pain, joint pains (arthralgias), dizziness, elevated blood pressure (hypertension) and elevated uric acid levels (
116:
1097:"FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions"
1297:
1166:
1022:
823:
Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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Luspatercept is indicated for the treatment of adults with transfusion-dependent anaemia associated with beta thalassaemia.
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1190:"Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with β-thalassemia"
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1167:"FDA Fast Track Designation Granted to Luspatercept for the Treatment of Patients with Beta-Thalassemia"
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Luspatercept is being evaluated for use in adults with non-transfusion dependent beta thalassemia.
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Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, et al. (March 2019).
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553:(blood clots) in patients who have risk factors for thrombosis who are taking luspatercept.
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Taher AT, Musallam KM, Cappellini MD (February 2021). "β-Thalassemias".
366:
1023:"FDA approves first therapy to treat patients with rare blood disorder"
609:
578:
332:
741:"Health product highlights 2021: Annexes of products approved in 2021"
1266:
772:"Reblozyl- luspatercept injection, powder, lyophilized, for solution"
566:
422:
1152:
This article incorporates text from this source, which is in the
1052:
This article incorporates text from this source, which is in the
413:
294:
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63:
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signaling. The reduction in SMAD signaling leads to enhanced
257:
189:
69:
45:
57:
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657:
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502:, is a medication used for the treatment of anemia in
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42:
1496:
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1278:
1067:"Reblozyl (luspatercept-aamt) FDA Approval History"
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1169:(Press release). Acceleron/Celgene. 18 May 2015
798:
796:
794:
792:
320:
715:"Summary Basis of Decision (SBD) for Reblozyl"
1251:
8:
166:
21:
569:(ActRIIb) linked to a protein derived from
1258:
1244:
1236:
997:"Luspatercept: Our Lead Product Candidate"
1215:
1205:
401:
1298:Methoxy polyethylene glycol-epoetin beta
1547:Drugs developed by Bristol Myers Squibb
1521:
882:
880:
651:
549:). There was also an increased risk of
365:
139:
977:. clinicaltrials.gov. 19 November 2021
693:Therapeutic Goods Administration (TGA)
667:Therapeutic Goods Administration (TGA)
20:
1107:from the original on 13 November 2019
1077:from the original on 13 November 2019
1037:from the original on 13 November 2019
955:. clinicaltrials.gov. 21 January 2022
125:
7:
838:Union Register of medicinal products
230:
889:The New England Journal of Medicine
421:
336:
1103:(Press release). 8 November 2019.
1033:(Press release). 8 November 2019.
999:. Acceleron Pharma. Archived from
14:
1455:HIF prolyl-hydroxylase inhibitors
1127:"Drug Trials Snapshots: Reblozyl"
863:U.S. Food and Drug Administration
859:"New Drug Therapy Approvals 2019"
1524:
1147:
1047:
455:
449:
38:
1396:Sodium ferric gluconate complex
575:transforming growth factor beta
567:human activin receptor type IIb
834:"Reblozyl Product information"
467:
461:
443:
1:
1425:Cyanocobalamin tannin complex
1207:10.1182/blood-2018-10-879247
1133:Food and Drug Administration
1029:Food and Drug Administration
624:Food and Drug Administration
617:Food and Drug Administration
515:Food and Drug Administration
498:, sold under the brand name
517:(FDA) considers it to be a
1573:
1177:– via Business Wire.
563:recombinant fusion protein
433:Chemical and physical data
111:ACE-536, luspatercept-aamt
939:National Cancer Institute
809:European Medicines Agency
519:first-in-class medication
508:myelodysplastic syndromes
1366:Ferrous glycine sulfate
1267:Antianemic preparations
557:Structure and mechanism
278: / Schedule D
689:"AusPAR: Luspatercept"
632:fast track designation
608:in collaboration with
212:Subcutaneous injection
901:10.1056/NEJMra2021838
1557:Recombinant proteins
1351:Ferric derisomaltose
630:status in 2013, and
266:(Prescription only)
25:
16:Pharmaceutical drug
865:. 31 December 2019
669:. 7 September 2021
561:Luspatercept is a
1512:
1511:
1376:Ferrous succinate
1361:Ferrous gluconate
1341:Ferrous carbonate
1336:Ferrous aspartate
1331:Ferrous ascorbate
1200:(12): 1279–1289.
1137:. 8 November 2019
721:. 23 October 2014
493:
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298:
286:
273:
261:
193:
160:
1564:
1529:
1528:
1527:
1520:
1430:Hydroxocobalamin
1386:Ferrous tartrate
1356:Ferrous fumarate
1346:Ferrous chloride
1321:Ferric hydroxide
1313:Iron supplements
1293:Darbepoetin alfa
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606:Acceleron Pharma
573:. It binds TGF (
571:immunoglobulin G
529:Luspatercept is
504:beta thalassemia
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1381:Ferrous sulfate
1307:
1280:Erythropoietins
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1234:
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1003:on 5 March 2017
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813:. 28 April 2020
804:"Reblozyl EPAR"
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749:. 3 August 2022
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695:. 28 April 2022
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1371:Ferrous iodine
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1288:Erythropoietin
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931:"Luspatercept"
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895:(8): 727–743.
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626:(FDA) awarded
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577:) superfamily
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1154:public domain
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1054:public domain
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565:derived from
564:
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547:hyperuricemia
540:
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299: Rx-only
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36:
34:Pronunciation
32:
29:Clinical data
27:
19:
1552:Orphan drugs
1504:Luspatercept
1503:
1391:Iron sucrose
1303:Peginesatide
1197:
1193:
1183:
1171:. Retrieved
1161:
1139:. Retrieved
1130:
1121:
1109:. Retrieved
1100:
1091:
1079:. Retrieved
1070:
1061:
1039:. Retrieved
1026:
1017:
1005:. Retrieved
1001:the original
991:
979:. Retrieved
969:
957:. Retrieved
947:
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892:
888:
869:15 September
867:. Retrieved
862:
853:
841:. Retrieved
837:
828:
817:26 September
815:. Retrieved
807:
781:17 September
779:. Retrieved
775:
751:. Retrieved
744:
735:
723:. Retrieved
718:
709:
697:. Retrieved
692:
683:
673:17 September
671:. Retrieved
666:
641:
621:
614:
599:
596:
589:maturation.
560:
544:
541:Side effects
536:
528:
525:Medical uses
512:
499:
496:Luspatercept
495:
494:
322:1373715-00-4
249:Legal status
243:Legal status
168:Luspatercept
149:License data
23:Luspatercept
18:
1473:Enarodustat
1463:Daprodustat
1440:Mecobalamin
1413:supplements
1406:Vitamin B12
1111:13 November
1081:13 November
1041:13 November
628:orphan drug
489: g·mol
307:Identifiers
135:MedlinePlus
108:Other names
99:Trade names
1541:Categories
1488:Vadadustat
1483:Roxadustat
1478:Molidustat
1468:Desidustat
1445:Folic acid
1435:Cobamamide
1411:folic acid
1141:26 January
663:"Reblozyl"
646:References
581:to reduce
551:thrombosis
478:Molar mass
403:AQK7UBA1LS
378:ChemSpider
313:CAS Number
1071:Drugs.com
917:232049825
634:in 2015.
622:The U.S.
615:The U.S.
602:developed
587:erythroid
531:indicated
347:347911311
205:Routes of
179:Pregnancy
127:Monograph
121:Drugs.com
1531:Medicine
1226:30617198
1105:Archived
1075:Archived
1035:Archived
909:33626255
776:DailyMed
753:25 March
699:28 April
638:Research
500:Reblozyl
358:DrugBank
219:ATC code
181:category
163:DailyMed
103:Reblozyl
90:-ər-sept
1217:6440118
1101:Celgene
843:3 March
610:Celgene
600:It was
593:History
579:ligands
513:The US
439:Formula
367:DB12281
333:PubChem
274::
235:)
229: (
227:B03XA06
194: D
165::
141:a620043
1517:Portal
1224:
1214:
1173:22 May
1007:22 May
915:
907:
725:29 May
423:D11701
289:℞-only
287:
276:℞-only
262:
161:
93:
1497:Other
1194:Blood
1135:(FDA)
1131:U.S.
1031:(FDA)
1027:U.S.
981:5 May
959:5 May
913:S2CID
811:(EMA)
86:luus-
1222:PMID
1175:2017
1143:2020
1113:2019
1083:2019
1043:2019
1009:2017
983:2022
961:2022
905:PMID
871:2020
845:2023
819:2020
783:2021
755:2024
727:2022
701:2022
675:2021
583:SMAD
506:and
465:1044
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