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Anti-amyloid drugs

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114:(FDA) in June 2021, in a controversial decision that led to the resignation of three advisers to the FDA in the absence of evidence that the medication is effective. The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer's disease and that it is the first new treatment approved for Alzheimer's since 2003. Aducanumab's approval is controversial for numerous reasons including ambiguous clinical trial results regarding 2867: 1647: 1459: 1388: 1147: 695: 129:
In November 2020, a panel of outside experts for the FDA concluded that a pivotal study of aducanumab failed to show strong evidence that the medication worked, citing questionable efficacy and multiple red flags found with the data analysis. There were also significant health risks associated with
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Lyu D, Lyu X, Huang L, Fang B (July 2023). "Effects of three kinds of anti-amyloid-β drugs on clinical, biomarker, neuroimaging outcomes and safety indexes: A systematic review and meta-analysis of phase II/III clinical trials in Alzheimer's disease".
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treated with anti-amyloid drugs would reach the brain volume associated with full Alzheimer's disease eight months earlier than those who received no such treatment. The significance of the brain volume loss caused by these drugs is unknown.
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or mild dementia. In clinical trials, it demonstrated modest efficacy in reducing relative cognitive decline compared to placebo. The most common side effects of lecanemab include headache, infusion-related reactions, and
135: 352:, and other anti-amyloid drugs. Hippocampal, ventricular, and whole brain volumes are reported in studies and declines in all three have been found. However, the affected parts of the brain are not fully understood. 1551:"EISAI'S APPROACH TO U.S. PRICING FOR LEQEMBI™ (LECANEMAB), A TREATMENT FOR EARLY ALZHEIMER'S DISEASE, SETS FORTH OUR CONCEPT OF "SOCIETAL VALUE OF MEDICINE" IN RELATION TO "PRICE OF MEDICINE" | News Release:2023" 271:
but slight clinical effect of these drugs emerges in patients with early AD after 18 months" and states, "The risk/benefit ratio of this class of drugs in early AD remains so far questionable after 18 months."
579:"High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 2: putative scenarios and timeline in case of approval, recommendations for use, implementation, and ethical considerations in France" 919: 283:, "Anti-Aβ antibodies represent a significant advance in the treatment of AD, but their effectiveness is moderate and much work remains to be done to improve their efficacy, safety and accessibility." 1444: 1026: 267:
A 2023 review found that "Anti-Aβ drugs have relatively low efficacy in preventing cognitive decline, and they reduce pathological productions with acceptable safety." A 2022 review finds "a
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In a 2023 commentary, the authors express concern that the results of the trials, which are based on scoring by patients and their caregivers, of these drugs could be confounded by
258:. Treatment is intended for patients with mild cognitive impairment or mild dementia stage of disease, which is the same population the treatment was studied in the clinical trials. 680: 1632: 1095: 1340: 639: 1525: 202:
for medical use in the United States in January 2023, and fully approved by the FDA in July 2023. Lecanemab was priced at $ 26,500 per year in the United States. The
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Sevigny J, Chiao P, Bussière T, Weinreb PH, Williams L, Maier M, et al. (September 2016). "The antibody aducanumab reduces Aβ plaques in Alzheimer's disease".
1825:"High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 1: Meta-analysis and review of efficacy and safety data, and medico-economical aspects" 130:
the medication; brain swelling or brain bleeding was found in 41% of patients enrolled in the studies. Nevertheless, the medication was approved under the FDA's
2100: 911: 1275: 530:"Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer's disease: patient outcomes, healthcare costs, and drug development" 1488: 953: 2887: 1432: 1062: 337:(ARIA) have been suggested as a possible cause of the accelerated brain volume loss. Others say it may be attributed to the reduction in amyloid plaques. 1865: 1018: 1365: 134:, and the FDA requires Biogen to perform follow-up reviews to assure the medication is a safe and effective treatment for Alzheimer's disease. The 1214: 2821: 334: 307: 249: 185: 1297: 1236: 668: 1620: 2093: 1085: 280: 1589: 1332: 631: 2257: 2126: 1510: 814:"Comparative Analysis of Aducanumab, Zagotenemab and Pioglitazone as Targeted Treatment Strategies for Alzheimer's Disease" 1165: 2857: 1754: 2352: 2086: 1626: 1521: 1482: 1438: 1369: 1240: 1126: 947: 674: 255: 111: 38: 1132: 276: 2838: 2288: 366: 291: 2078: 1267: 131: 1476: 941: 326: 268: 206:
ruled against approving the drug. In Great Britain, the drug was approved but will not be covered by the English
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was asked to investigate interaction between the drug company and the FDA prior to the medication's approval.
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and is accelerated by anti-amyloid drugs developed to treat it. One meta-analysis found that people with
396:"News & views: anti-amyloid antibodies and novel emerging approaches to Alzheimer's disease in 2023" 242: 26: 95:(Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by 1196: 1950:"Accelerated Brain Volume Loss Caused by Anti–β-Amyloid Drugs: A Systematic Review and Meta-analysis" 770: 199: 176: 104: 2215: 2144: 1090: 975:
Mahase E (June 2021). "Three FDA advisory panel members resign over approval of Alzheimer's drug".
234: 164: 88: 80: 37:, but it did not show effectiveness in later-stage trials. The first drug to be approved by the US 2709: 2510: 2381: 2064: 1802: 1201: 1057: 1000: 892: 794: 608: 507: 365:
The approved anti-amyloid drugs were developed after years of unsuccessful attempts to develop a
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Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, et al. (May 2021).
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produced by adverse effects. They also support running studies designed to distinguish between
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Concerns have been raised about the high cost of the drugs and accessibility to patients.
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Liu KY, Villain N, Ayton S, Ackley SF, Planche V, Howard R, et al. (2 May 2023).
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Abyadeh M, Gupta V, Gupta V, Chitranshi N, Wu Y, Amirkhani A, et al. (2021).
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Donanemab was approved for medical use in the United States in July 2024 by the
1722: 1418: 545: 412: 188:, a side effect known to occur with the class of antibodies targeting amyloid. 2777: 2694: 2674: 2653: 2648: 2616: 2552: 2547: 2441: 2436: 2426: 2421: 2416: 2401: 2396: 2367: 2333: 2186: 2181: 2155: 1790: 1197:"Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug" 1019:"3 Experts Have Resigned From An FDA Committee Over Alzheimer's Drug Approval" 345: 287: 76: 67: 42: 2042: 1973: 1853: 1210: 485: 2719: 2699: 2643: 2631: 2621: 2596: 2562: 2495: 2456: 2446: 2431: 2317: 2312: 2211: 2201: 2191: 2140: 1117: 349: 341: 230: 221: 160: 151: 2060: 1991: 1934: 1861: 1798: 1740: 1691: 996: 888: 847: 790: 747: 604: 563: 503: 431: 1682: 1665: 1433:"FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval" 2638: 2113: 1053:"Three F.D.A. Advisers Resign Over Agency's Approval of Alzheimer's Drug" 115: 782: 2165: 1707:"Alzheimer Disease: An Update on Pathobiology and Treatment Strategies" 136:
Office of Inspector General, US Department of Health and Human Services
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Perneczky R, Dom G, Chan A, Falkai P, Bassetti C (11 September 2023).
988: 912:"Biogen takes full control of troubled Aduhelm in revamped Eisai deal" 729: 466: 448:
Perneczky R, Dom G, Chan A, Falkai P, Bassetti C (11 September 2023).
33:. The first drug in the class to be developed, in the early 2000s, is 1298:"Biogen will stop selling its controversial Alzheimer's drug Aduhelm" 863:"What lessons can be learned from failed Alzheimer's disease trials?" 195: 96: 1755:"FDA approves treatment for Alzheimer's disease - The Yucatan Times" 1407:"Debate rages over Alzheimer's drug lecanemab as UK limits approval" 1118:
Advancing Health Through Innovation: New Drug Therapy Approvals 2021
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Aducanumab was approved for medical use in the United States by the
1366:"FDA Grants Accelerated Approval for Alzheimer's Disease Treatment" 1650:
This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
1237:"FDA's Decision to Approve New Treatment for Alzheimer's Disease" 1150:
This article incorporates text from this source, which is in the
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This article incorporates text from this source, which is in the
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Biogen abandoned the drug in January 2024, for financial reasons.
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for bone, musculoskeletal, circulatory, and neurologic systems
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As of 2022, none of these drugs has been approved by the
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Brockmann R, Nixon J, Love BL, Yunusa I (1 March 2023).
669:"FDA Grants Accelerated Approval for Alzheimer's Drug" 310:
are a relatively uncommon but serious adverse effect.
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Accelerated brain volume loss has been reported with
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It is given via 1670:The New England Journal of Medicine 1531:from the original on 7 January 2023 1376:from the original on 7 January 2023 1278:from the original on 13 August 2021 190:Lecanemab was jointly developed by 2888:Anti-amyloid monoclonal antibodies 922:from the original on 21 March 2022 14: 1217:from the original on 20 July 2022 1029:from the original on 11 June 2021 642:from the original on 14 June 2021 534:Lancet Regional Health - Americas 333:The mechanism is not understood. 277:European Association of Neurology 2865: 1645: 1635:from the original on 2 July 2024 1491:from the original on 9 July 2023 1477:"Drug Approval Package: Leqembi" 1457: 1447:from the original on 6 July 2023 1386: 1247:from the original on 8 June 2021 1145: 693: 683:from the original on 8 June 2021 281:European Psychiatric Association 220:This section is an excerpt from 150:This section is an excerpt from 66:This section is an excerpt from 2207:Meclofenoxate (centrophenoxine) 122:. The FDA considers it to be a 1631:(Press release). 2 July 2024. 1443:(Press release). 6 July 2023. 1195:Belluck P (22 November 2021). 679:(Press release). 7 June 2021. 1: 2011:European Journal of Neurology 880:10.1586/17512433.2015.1034690 454:European Journal of Neurology 314:Accelerated brain volume loss 275:From a 2023 statement by the 241:. Donanemab was developed by 1966:10.1212/WNL.0000000000207156 1845:10.1016/j.neurol.2022.06.012 1627:Food and Drug Administration 1522:Food and Drug Administration 1483:Food and Drug Administration 1439:Food and Drug Administration 1370:Food and Drug Administration 1241:Food and Drug Administration 1127:Food and Drug Administration 948:Food and Drug Administration 675:Food and Drug Administration 596:10.1016/j.neurol.2022.08.002 256:Food and Drug Administration 132:accelerated approval pathway 112:Food and Drug Administration 39:Food and Drug Administration 1266:Gumbrecht J (9 July 2021). 1084:McGinley L (22 June 2021). 400:Molecular Neurodegeneration 367:disease-modifying treatment 2904: 1916:10.1093/braincomms/fcad175 1723:10.1016/j.cell.2019.09.001 1511:"Lecanemab Summary Review" 1419:10.1038/d41586-024-02720-y 546:10.1016/j.lana.2023.100467 413:10.1186/s13024-023-00656-x 237:used for the treatment of 219: 149: 103:. Aducanumab is given via 65: 2816: 2034:10067/1987770151162165141 1791:10.1016/j.arr.2023.101959 1405:Kwon D (22 August 2024). 477:10067/1987770151162165141 369:for Alzheimer's disease. 327:mild cognitive impairment 294:and symptomatic effects. 269:statistically significant 204:European Medicines Agency 181:mild cognitive impairment 124:first-in-class medication 55:European Medicines Agency 1779:Ageing Research Reviews 1372:(FDA). 6 January 2023. 1131:(Report). 13 May 2022. 910:Liu A (15 March 2022). 23:anti-amyloid antibodies 2734:Angiogenesis inhibitor 1368:(Press release). U.S. 25:(AAA), are a class of 1683:10.1056/NEJMoa2100708 321:loss is a symptom of 243:Eli Lilly and Company 27:monoclonal antibodies 1903:Brain Communications 1243:(FDA). 7 June 2021. 200:accelerated approval 177:intravenous infusion 105:intravenous infusion 1960:(20): e2114–e2124. 1487:. 6 February 2023. 1339:. 11 January 2023. 1091:The Washington Post 861:Toyn J (May 2015). 783:10.1038/nature19323 775:2016Natur.537...50S 356:Society and culture 323:Alzheimer's disease 239:Alzheimer's disease 235:monoclonal antibody 169:Alzheimer's disease 165:monoclonal antibody 89:monoclonal antibody 85:Alzheimer's disease 81:monoclonal antibody 31:Alzheimer's disease 29:developed to treat 2843:Never to phase III 2612:Anti-amyloid drugs 1832:Revue Neurologique 1202:The New York Times 1058:The New York Times 583:Revue Neurologique 171:. Lecanemab is an 83:designed to treat 19:Anti-amyloid drugs 2853: 2852: 2812: 2811: 2757: 2756: 2728: 2727: 2591: 2590: 2376: 2375: 2347: 2346: 2255: 2254: 2175:Other medications 2116:agents (ATC code 2024:10.1111/ene.16049 1838:(10): 1011–1030. 1676:(18): 1691–1704. 989:10.1136/bmj.n1503 818:Aging and Disease 730:10.1136/bmj.n1682 467:10.1111/ene.16049 292:disease-modifying 198:. It was granted 179:to patients with 2895: 2870: 2869: 2868: 2861: 2768: 2739: 2602: 2519:Alacizumab pegol 2387: 2358: 2303: 2282: 2275: 2268: 2259: 2110:Psychoanaleptics 2103: 2096: 2089: 2080: 2073: 2072: 2054: 2036: 2026: 2002: 1996: 1995: 1985: 1945: 1939: 1938: 1928: 1918: 1894: 1881: 1880: 1878: 1876: 1870: 1847: 1829: 1820: 1811: 1810: 1773: 1767: 1766: 1764: 1762: 1751: 1745: 1744: 1734: 1702: 1696: 1695: 1685: 1661: 1655: 1649: 1648: 1644: 1642: 1640: 1617: 1606: 1605: 1603: 1601: 1586: 1580: 1579: 1572: 1566: 1565: 1563: 1561: 1547: 1541: 1540: 1538: 1536: 1530: 1515: 1507: 1501: 1500: 1498: 1496: 1473: 1467: 1461: 1460: 1456: 1454: 1452: 1429: 1423: 1422: 1402: 1396: 1390: 1389: 1385: 1383: 1381: 1362: 1353: 1352: 1350: 1348: 1329: 1318: 1317: 1315: 1313: 1294: 1288: 1287: 1285: 1283: 1263: 1257: 1256: 1254: 1252: 1233: 1227: 1226: 1224: 1222: 1192: 1186: 1185: 1183: 1181: 1170:Associated Press 1161: 1155: 1149: 1148: 1144: 1142: 1140: 1122: 1114: 1108: 1107: 1105: 1103: 1081: 1075: 1074: 1072: 1070: 1048: 1039: 1038: 1036: 1034: 1025:. 11 June 2021. 1015: 1009: 1008: 972: 966: 965: 963: 961: 952:. 22 June 2021. 938: 932: 931: 929: 927: 907: 901: 900: 882: 858: 852: 851: 841: 824:(8): 1964–1976. 809: 803: 802: 758: 752: 751: 741: 709: 703: 697: 696: 692: 690: 688: 665: 652: 651: 649: 647: 628: 617: 616: 598: 589:(10): 999–1010. 574: 568: 567: 557: 525: 516: 515: 497: 479: 469: 445: 436: 435: 425: 415: 394:Gandy S (2023). 391: 361:Drug development 21:, also known as 2903: 2902: 2898: 2897: 2896: 2894: 2893: 2892: 2878: 2877: 2876: 2866: 2864: 2856: 2854: 2849: 2848: 2833:Clinical trials 2808: 2787: 2753: 2724: 2658: 2587: 2505: 2482: 2461: 2372: 2353:Musculoskeletal 2343: 2322: 2292: 2286: 2256: 2251: 2226: 2170: 2136:Benzgalantamine 2121: 2107: 2077: 2076: 2004: 2003: 1999: 1947: 1946: 1942: 1896: 1895: 1884: 1874: 1872: 1868: 1827: 1822: 1821: 1814: 1775: 1774: 1770: 1760: 1758: 1753: 1752: 1748: 1704: 1703: 1699: 1663: 1662: 1658: 1646: 1638: 1636: 1619: 1618: 1609: 1599: 1597: 1588: 1587: 1583: 1574: 1573: 1569: 1559: 1557: 1549: 1548: 1544: 1534: 1532: 1528: 1513: 1509: 1508: 1504: 1494: 1492: 1475: 1474: 1470: 1458: 1450: 1448: 1431: 1430: 1426: 1404: 1403: 1399: 1387: 1379: 1377: 1364: 1363: 1356: 1346: 1344: 1331: 1330: 1321: 1311: 1309: 1296: 1295: 1291: 1281: 1279: 1265: 1264: 1260: 1250: 1248: 1235: 1234: 1230: 1220: 1218: 1194: 1193: 1189: 1179: 1177: 1163: 1162: 1158: 1146: 1138: 1136: 1120: 1116: 1115: 1111: 1101: 1099: 1083: 1082: 1078: 1068: 1066: 1050: 1049: 1042: 1032: 1030: 1017: 1016: 1012: 974: 973: 969: 959: 957: 940: 939: 935: 925: 923: 909: 908: 904: 860: 859: 855: 811: 810: 806: 769:(7618): 50–56. 760: 759: 755: 711: 710: 706: 694: 686: 684: 667: 666: 655: 645: 643: 630: 629: 620: 576: 575: 571: 527: 526: 519: 447: 446: 439: 393: 392: 388: 383: 375: 363: 358: 316: 305: 300: 298:Adverse effects 265: 260: 259: 225: 217: 212: 211: 155: 147: 142: 141: 71: 63: 51: 12: 11: 5: 2901: 2899: 2891: 2890: 2880: 2879: 2875: 2874: 2851: 2850: 2847: 2846: 2845: 2844: 2841: 2830: 2824: 2818: 2817: 2814: 2813: 2810: 2809: 2807: 2806: 2801: 2795: 2793: 2789: 2788: 2786: 2785: 2780: 2774: 2772: 2765: 2759: 2758: 2755: 2754: 2752: 2751: 2745: 2743: 2736: 2730: 2729: 2726: 2725: 2723: 2722: 2717: 2712: 2707: 2702: 2697: 2692: 2687: 2682: 2677: 2672: 2666: 2664: 2660: 2659: 2657: 2656: 2651: 2646: 2641: 2636: 2635: 2634: 2629: 2624: 2619: 2608: 2606: 2599: 2593: 2592: 2589: 2588: 2586: 2585: 2580: 2575: 2570: 2565: 2560: 2555: 2550: 2545: 2540: 2535: 2530: 2521: 2515: 2513: 2507: 2506: 2504: 2503: 2498: 2492: 2490: 2484: 2483: 2481: 2480: 2475: 2469: 2467: 2463: 2462: 2460: 2459: 2454: 2449: 2444: 2439: 2434: 2429: 2424: 2419: 2414: 2409: 2404: 2399: 2393: 2391: 2384: 2378: 2377: 2374: 2373: 2371: 2370: 2364: 2362: 2355: 2349: 2348: 2345: 2344: 2342: 2341: 2336: 2330: 2328: 2324: 2323: 2321: 2320: 2315: 2309: 2307: 2300: 2294: 2293: 2287: 2285: 2284: 2277: 2270: 2262: 2253: 2252: 2250: 2249: 2244: 2238: 2236: 2228: 2227: 2225: 2224: 2219: 2209: 2204: 2199: 2194: 2189: 2184: 2178: 2176: 2172: 2171: 2169: 2168: 2163: 2158: 2153: 2148: 2138: 2132: 2130: 2127:AChE inhibitor 2123: 2122: 2108: 2106: 2105: 2098: 2091: 2083: 2075: 2074: 1997: 1940: 1909:(3): fcad175. 1901:. Commentary. 1882: 1812: 1768: 1757:. 12 July 2024 1746: 1717:(2): 312–339. 1697: 1656: 1607: 1581: 1567: 1555:Eisai Co., Ltd 1542: 1502: 1468: 1424: 1397: 1354: 1319: 1289: 1258: 1228: 1187: 1156: 1109: 1076: 1040: 1010: 967: 933: 902: 873:(3): 267–269. 853: 804: 753: 704: 653: 618: 569: 517: 437: 385: 384: 382: 379: 374: 371: 362: 359: 357: 354: 315: 312: 304: 301: 299: 296: 264: 261: 252:and headache. 226: 218: 216: 213: 156: 148: 146: 143: 120:adverse events 72: 64: 62: 59: 50: 49:Approved drugs 47: 13: 10: 9: 6: 4: 3: 2: 2900: 2889: 2886: 2885: 2883: 2873: 2863: 2859: 2842: 2840: 2837: 2836: 2834: 2831: 2828: 2825: 2823: 2820: 2819: 2815: 2805: 2804:Landogrozumab 2802: 2800: 2797: 2796: 2794: 2790: 2784: 2781: 2779: 2776: 2775: 2773: 2769: 2766: 2764: 2763:Growth factor 2760: 2750: 2747: 2746: 2744: 2740: 2737: 2735: 2731: 2721: 2718: 2716: 2713: 2711: 2708: 2706: 2703: 2701: 2698: 2696: 2693: 2691: 2688: 2686: 2683: 2681: 2678: 2676: 2673: 2671: 2668: 2667: 2665: 2661: 2655: 2652: 2650: 2647: 2645: 2642: 2640: 2637: 2633: 2630: 2628: 2625: 2623: 2620: 2618: 2615: 2614: 2613: 2610: 2609: 2607: 2603: 2600: 2598: 2594: 2584: 2581: 2579: 2576: 2574: 2573:Ralpancizumab 2571: 2569: 2566: 2564: 2561: 2559: 2556: 2554: 2551: 2549: 2546: 2544: 2541: 2539: 2536: 2534: 2531: 2529: 2525: 2522: 2520: 2517: 2516: 2514: 2512: 2508: 2502: 2499: 2497: 2494: 2493: 2491: 2489: 2485: 2479: 2476: 2474: 2471: 2470: 2468: 2464: 2458: 2455: 2453: 2450: 2448: 2445: 2443: 2440: 2438: 2435: 2433: 2430: 2428: 2425: 2423: 2420: 2418: 2415: 2413: 2410: 2408: 2407:Ascrinvacumab 2405: 2403: 2400: 2398: 2395: 2394: 2392: 2388: 2385: 2383: 2379: 2369: 2366: 2365: 2363: 2359: 2356: 2354: 2350: 2340: 2337: 2335: 2332: 2331: 2329: 2325: 2319: 2316: 2314: 2311: 2310: 2308: 2304: 2301: 2299: 2295: 2290: 2283: 2278: 2276: 2271: 2269: 2264: 2263: 2260: 2248: 2245: 2243: 2240: 2239: 2237: 2234: 2231:Experimental 2229: 2223: 2220: 2217: 2213: 2210: 2208: 2205: 2203: 2200: 2198: 2197:Ginkgo folium 2195: 2193: 2190: 2188: 2185: 2183: 2180: 2179: 2177: 2173: 2167: 2164: 2162: 2159: 2157: 2154: 2152: 2149: 2146: 2142: 2139: 2137: 2134: 2133: 2131: 2128: 2124: 2119: 2115: 2111: 2104: 2099: 2097: 2092: 2090: 2085: 2084: 2081: 2070: 2066: 2062: 2058: 2053: 2048: 2044: 2040: 2035: 2030: 2025: 2020: 2017:(2): e16049. 2016: 2012: 2008: 2001: 1998: 1993: 1989: 1984: 1979: 1975: 1971: 1967: 1963: 1959: 1955: 1951: 1944: 1941: 1936: 1932: 1927: 1922: 1917: 1912: 1908: 1904: 1900: 1893: 1891: 1889: 1887: 1883: 1867: 1863: 1859: 1855: 1851: 1846: 1841: 1837: 1833: 1826: 1819: 1817: 1813: 1808: 1804: 1800: 1796: 1792: 1788: 1784: 1780: 1772: 1769: 1756: 1750: 1747: 1742: 1738: 1733: 1728: 1724: 1720: 1716: 1712: 1708: 1701: 1698: 1693: 1689: 1684: 1679: 1675: 1671: 1667: 1660: 1657: 1653: 1652:public domain 1634: 1630: 1628: 1622: 1616: 1614: 1612: 1608: 1596:. 2 July 2024 1595: 1591: 1585: 1582: 1577: 1571: 1568: 1556: 1552: 1546: 1543: 1527: 1523: 1519: 1512: 1506: 1503: 1490: 1486: 1484: 1478: 1472: 1469: 1465: 1464:public domain 1446: 1442: 1440: 1434: 1428: 1425: 1420: 1416: 1412: 1408: 1401: 1398: 1394: 1393:public domain 1375: 1371: 1367: 1361: 1359: 1355: 1342: 1338: 1334: 1328: 1326: 1324: 1320: 1307: 1303: 1299: 1293: 1290: 1277: 1273: 1269: 1262: 1259: 1246: 1242: 1238: 1232: 1229: 1216: 1212: 1208: 1204: 1203: 1198: 1191: 1188: 1175: 1171: 1167: 1160: 1157: 1153: 1152:public domain 1134: 1130: 1128: 1119: 1113: 1110: 1097: 1093: 1092: 1087: 1080: 1077: 1064: 1060: 1059: 1054: 1047: 1045: 1041: 1028: 1024: 1020: 1014: 1011: 1006: 1002: 998: 994: 990: 986: 982: 978: 971: 968: 955: 951: 949: 943: 937: 934: 921: 917: 916:Fierce Pharma 913: 906: 903: 898: 894: 890: 886: 881: 876: 872: 868: 864: 857: 854: 849: 845: 840: 835: 831: 827: 823: 819: 815: 808: 805: 800: 796: 792: 788: 784: 780: 776: 772: 768: 764: 757: 754: 749: 745: 740: 735: 731: 727: 723: 719: 715: 708: 705: 701: 700:public domain 682: 678: 676: 670: 664: 662: 660: 658: 654: 641: 637: 633: 627: 625: 623: 619: 614: 610: 606: 602: 597: 592: 588: 584: 580: 573: 570: 565: 561: 556: 551: 547: 543: 539: 535: 532:. Viewpoint. 531: 524: 522: 518: 513: 509: 505: 501: 496: 491: 487: 483: 478: 473: 468: 463: 460:(2): e16049. 459: 455: 451: 444: 442: 438: 433: 429: 424: 419: 414: 409: 405: 401: 397: 390: 387: 380: 378: 372: 370: 368: 360: 355: 353: 351: 347: 343: 338: 336: 331: 328: 324: 320: 313: 311: 309: 302: 297: 295: 293: 289: 284: 282: 278: 273: 270: 262: 257: 253: 251: 246: 244: 240: 236: 232: 228: 223: 214: 209: 205: 201: 197: 193: 189: 187: 182: 178: 174: 170: 166: 162: 158: 153: 144: 139: 137: 133: 127: 125: 121: 117: 113: 108: 106: 102: 98: 94: 90: 86: 82: 78: 74: 69: 60: 58: 56: 48: 46: 44: 40: 36: 32: 28: 24: 20: 16: 2799:Domagrozumab 2690:Galcanezumab 2685:Fremanezumab 2670:Bapineuzumab 2627:Gantenerumab 2611: 2568:Idarucizumab 2558:Etaracizumab 2543:Caplacizumab 2538:Brolucizumab 2247:Verubecestat 2242:Lanabecestat 2161:Rivastigmine 2014: 2010: 2000: 1957: 1953: 1943: 1906: 1902: 1873:. Retrieved 1835: 1831: 1782: 1778: 1771: 1759:. 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Retrieved 635: 586: 582: 572: 537: 533: 457: 453: 403: 399: 389: 376: 364: 339: 332: 319:Brain volume 317: 306: 285: 274: 266: 247: 229: 227: 173:amyloid beta 159: 157: 128: 109: 93:amyloid beta 75: 73: 52: 35:bapineuzumab 22: 18: 17: 15: 2829:from market 2783:Trevogrumab 2749:Ranibizumab 2715:Solanezumab 2710:Semorinemab 2705:Refanezumab 2680:Eptinezumab 2583:Vanucizumab 2578:Tadocizumab 2533:Bococizumab 2528:Ranibizumab 2524:Bevacizumab 2501:Volociximab 2452:Ramucirumab 2412:Bentracimab 2382:Circulatory 2339:Romosozumab 2289:Monoclonals 2222:Nicergoline 2151:Galantamine 2129:medications 2120:and others) 1282:1 September 960:1 September 830:10.14336/AD 2778:Bimagrumab 2695:Ozanezumab 2675:Crenezumab 2654:Opicinumab 2649:Fulranumab 2617:Aducanumab 2597:Neurologic 2553:Emicizumab 2548:Demcizumab 2442:Nesvacumab 2437:Inclacumab 2427:Evolocumab 2422:Evinacumab 2417:Enoticumab 2402:Alirocumab 2397:Abelacimab 2368:Stamulumab 2334:Blosozumab 2235:inhibitors 2216:+donepezil 2187:Bifemelane 2182:Aducanumab 2156:Ipidacrine 2145:+memantine 1875:10 January 1785:: 101959. 1347:21 January 1312:1 February 1139:22 January 540:: 100467. 381:References 346:aducanumab 288:unblinding 87:. It is a 77:Aducanumab 68:Aducanumab 61:Aducanumab 45:—in 2021. 43:aducanumab 2839:Phase III 2827:Withdrawn 2792:Humanized 2742:Humanized 2720:Tanezumab 2700:Ponezumab 2663:Humanized 2644:Fasinumab 2632:Lecanemab 2622:Donanemab 2563:Faricimab 2511:Humanized 2496:Abciximab 2478:Imciromab 2473:Biciromab 2457:Rinucumab 2447:Orticumab 2432:Icrucumab 2327:Humanized 2318:Denosumab 2313:Burosumab 2212:Memantine 2202:Lecanemab 2192:Donanemab 2141:Donepezil 2069:261694703 2043:1351-5101 1974:0028-3878 1954:Neurology 1854:0035-3787 1807:258808777 1600:15 August 1535:7 January 1380:7 January 1211:0362-4331 1005:235405355 983:: n1503. 799:205250312 724:: n1682. 613:253349289 512:261694703 486:1351-5101 406:(1): 66. 350:donanemab 342:lecanemab 231:Donanemab 222:Donanemab 215:Donanemab 161:Lecanemab 152:Lecanemab 145:Lecanemab 41:(FDA) is 2882:Category 2872:Medicine 2639:Erenumab 2488:Chimeric 2114:dementia 2061:37697714 2052:11235913 1992:36973044 1983:10186239 1935:37389302 1926:10306158 1866:Archived 1862:36184326 1799:37217078 1741:31564456 1692:33720637 1633:Archived 1594:DailyMed 1526:Archived 1489:Archived 1445:Archived 1374:Archived 1341:Archived 1337:DailyMed 1306:Archived 1302:ABC News 1276:Archived 1245:Archived 1215:Archived 1174:Archived 1133:Archived 1096:Archived 1063:Archived 1027:Archived 997:34117086 954:Archived 926:21 March 920:Archived 897:35158630 889:25860157 848:34881080 791:27582220 748:34226181 681:Archived 640:Archived 636:DailyMed 605:36336488 564:36908502 504:37697714 495:11235913 432:37749530 423:10518943 279:and the 263:Efficacy 116:efficacy 2166:Tacrine 2112:: Anti- 1761:15 July 1732:6778042 1524:(FDA). 1520:. U.S. 1239:. U.S. 1221:20 July 1102:24 June 1069:14 June 1033:11 June 839:8612603 771:Bibcode 739:8258645 646:14 June 555:9996432 2858:Portal 2822:WHO-EM 2067:  2059:  2049:  2041:  1990:  1980:  1972:  1933:  1923:  1860:  1852:  1805:  1797:  1739:  1729:  1690:  1639:2 July 1495:8 July 1451:6 July 1411:Nature 1251:7 June 1209:  1180:8 June 1003:  995:  895:  887:  846:  836:  797:  789:  763:Nature 746:  736:  687:7 June 611:  603:  562:  552:  510:  502:  492:  484:  430:  420:  196:Biogen 97:Biogen 2771:Human 2605:Human 2466:Mouse 2390:Human 2361:Human 2306:Human 2065:S2CID 1869:(PDF) 1828:(PDF) 1803:S2CID 1629:(FDA) 1625:U.S. 1529:(PDF) 1514:(PDF) 1485:(FDA) 1481:U.S. 1441:(FDA) 1437:U.S. 1129:(FDA) 1125:U.S. 1121:(PDF) 1001:S2CID 950:(FDA) 946:U.S. 893:S2CID 795:S2CID 677:(FDA) 673:U.S. 609:S2CID 508:S2CID 192:Eisai 101:Eisai 2298:Bone 2233:BACE 2118:N06D 2057:PMID 2039:ISSN 1988:PMID 1970:ISSN 1931:PMID 1877:2024 1858:PMID 1850:ISSN 1795:PMID 1763:2024 1737:PMID 1711:Cell 1688:PMID 1641:2024 1602:2024 1562:2024 1537:2023 1497:2023 1453:2023 1382:2023 1349:2023 1314:2024 1284:2021 1253:2021 1223:2022 1207:ISSN 1182:2021 1141:2023 1104:2021 1071:2021 1035:2021 993:PMID 962:2021 928:2022 885:PMID 844:PMID 787:PMID 744:PMID 689:2021 648:2021 601:PMID 560:PMID 500:PMID 482:ISSN 428:PMID 373:Cost 194:and 99:and 2047:PMC 2029:hdl 2019:doi 1978:PMC 1962:doi 1958:100 1921:PMC 1911:doi 1840:doi 1836:178 1787:doi 1727:PMC 1719:doi 1715:179 1678:doi 1674:384 1415:doi 1272:CNN 1023:NPR 985:doi 981:373 977:BMJ 875:doi 834:PMC 826:doi 779:doi 767:537 734:PMC 726:doi 722:374 718:BMJ 591:doi 587:178 550:PMC 542:doi 490:PMC 472:hdl 462:doi 418:PMC 408:doi 208:NHS 2884:: 2835:: 2063:. 2055:. 2045:. 2037:. 2027:. 2015:31 2013:. 2009:. 1986:. 1976:. 1968:. 1956:. 1952:. 1929:. 1919:. 1905:. 1885:^ 1864:. 1856:. 1848:. 1834:. 1830:. 1815:^ 1801:. 1793:. 1783:88 1781:. 1735:. 1725:. 1713:. 1709:. 1686:. 1672:. 1668:. 1623:. 1610:^ 1592:. 1553:. 1516:. 1479:. 1435:. 1413:. 1409:. 1357:^ 1335:. 1322:^ 1304:. 1300:. 1274:. 1270:. 1213:. 1205:. 1199:. 1172:. 1168:. 1123:. 1094:. 1088:. 1061:. 1055:. 1043:^ 1021:. 999:. 991:. 979:. 944:. 918:. 914:. 891:. 883:. 869:. 865:. 842:. 832:. 822:12 820:. 816:. 793:. 785:. 777:. 765:. 742:. 732:. 720:. 716:. 671:. 656:^ 638:. 634:. 621:^ 607:. 599:. 585:. 581:. 558:. 548:. 538:20 536:. 520:^ 506:. 498:. 488:. 480:. 470:. 458:31 456:. 452:. 440:^ 426:. 416:. 404:18 402:. 398:. 348:, 344:, 245:. 126:. 107:. 57:. 2860:: 2526:/ 2281:e 2274:t 2267:v 2218:) 2214:( 2147:) 2143:( 2102:e 2095:t 2088:v 2071:. 2031:: 2021:: 1994:. 1964:: 1937:. 1913:: 1907:5 1879:. 1842:: 1809:. 1789:: 1765:. 1743:. 1721:: 1694:. 1680:: 1654:. 1643:. 1604:. 1578:. 1564:. 1539:. 1499:. 1466:. 1455:. 1421:. 1417:: 1395:. 1384:. 1351:. 1316:. 1286:. 1255:. 1225:. 1184:. 1154:. 1143:. 1106:. 1073:. 1037:. 1007:. 987:: 964:. 930:. 899:. 877:: 871:8 850:. 828:: 801:. 781:: 773:: 750:. 728:: 702:. 691:. 650:. 615:. 593:: 566:. 544:: 514:. 474:: 464:: 434:. 410:: 224:. 154:. 70:.

Index

monoclonal antibodies
Alzheimer's disease
bapineuzumab
Food and Drug Administration
aducanumab
European Medicines Agency
Aducanumab
Aducanumab
monoclonal antibody
Alzheimer's disease
monoclonal antibody
amyloid beta
Biogen
Eisai
intravenous infusion
Food and Drug Administration
efficacy
adverse events
first-in-class medication
accelerated approval pathway
Office of Inspector General, US Department of Health and Human Services
Lecanemab
Lecanemab
monoclonal antibody
Alzheimer's disease
amyloid beta
intravenous infusion
mild cognitive impairment
amyloid-related imaging abnormalities
Eisai

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