{"id":"aducanumab","rwe":[{"pmid":"41885326","year":"2026","title":"Incidence of amyloid-related imaging abnormalities and health resource utilization in patients with Alzheimer disease receiving monoclonal antibody treatments: A real-world evidence study.","finding":"","journal":"Journal of managed care & specialty pharmacy","studyType":"Clinical Study"},{"pmid":"41874248","year":"2026","title":"Drugs for dementia.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"},{"pmid":"41837605","year":"2026","title":"Cost-effectiveness of traditional and novel neurotherapeutic agents for Alzheimer's disease: A systematic review.","finding":"","journal":"Journal of Alzheimer's disease : JAD","studyType":"Clinical Study"},{"pmid":"41760995","year":"2026","title":"The evolving landscape of amyloid-targeting therapies in Alzheimer's disease: progress and challenges.","finding":"","journal":"Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology","studyType":"Clinical Study"},{"pmid":"41756816","year":"2026","title":"Increased risk of infusion-related reactions switching between monoclonal antibodies for Alzheimer's disease: A case series.","finding":"","journal":"Alzheimer's & dementia (Amsterdam, Netherlands)","studyType":"Clinical Study"}],"tags":[{"label":"Amyloid Beta-directed Antibody","category":"class"},{"label":"Monoclonal Antibody","category":"modality"},{"label":"Amyloid beta A4 protein","category":"target"},{"label":"APP","category":"gene"},{"label":"N06DX03","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Alzheimer's disease","category":"indication"},{"label":"Biogen Inc","category":"company"},{"label":"Approved 2020s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":739.328,"date":"","count":74,"signal":"Amyloid related imaging abnormality-oedema/effusion","source":"DrugCentral FAERS","actionTaken":"Reported 74 times (LLR=739)"},{"llr":426.206,"date":"","count":43,"signal":"Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=426)"}],"commonSideEffects":[],"specialPopulations":{"Pregnancy":"There are no adequate data on ADUHELM use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.. Data. Animal DataIntravenous administration of aducanumab-avwa (0, 100, 300, or 1000 mg/kg/week) to female rats through organogenesis had no adverse effect on embryofetal development.Intravenous administration of aducanumab-avwa (0, 100, 300, or 1000 mg/kg/week) to female rats throughout pregnancy and lactation had no adverse effects on pre- or postnatal development.The relevance of these data to humans is limited because aggregated amyloid beta, the pharmacological target of aducanumab-avwa, is not present in rat.","Geriatric use":"In Studies and 2, the age of patients ranged from 50 to 85 years, with mean age of 70 years; 79% were 65 and older, and 32% were 75 and older. There were no notable differences in the incidence of adverse reactions between these age groups, and no additional safety concerns in patients 65 years of age and older compared to younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Biogen","patents":[],"pricing":[],"_fixedAt":"2026-03-30T13:04:10.178742","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ADUCANUMAB","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:24:08.563309+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Aducanumab","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:24:16.529746+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:24:15.258032+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ADUCANUMAB","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:24:15.484652+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Amyloid-beta A4 protein binding agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:24:16.529678+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3039540/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:24:16.196809+00:00"}},"allNames":"aduhelm","offLabel":[],"synonyms":["aducanumab","aducanumab-avwa","aduhelm","BIIB037"],"timeline":[{"date":"2021-06-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Biogen Inc)"}],"brandName":"Aduhelm","ecosystem":[{"indication":"Alzheimer's disease","otherDrugs":[{"name":"donepezil","slug":"donepezil","company":"Eisai Inc"},{"name":"epicriptine","slug":"epicriptine","company":""},{"name":"galantamine","slug":"galantamine","company":"Janssen Pharms"},{"name":"lecanemab","slug":"lecanemab","company":"Eisai Inc"}],"globalPrevalence":55000000}],"mechanism":{"target":"Amyloid beta A4 protein","novelty":"Follow-on","targets":[{"gene":"APP","source":"DrugCentral","target":"Amyloid beta A4 protein","protein":"Amyloid beta A4 protein"}],"moaClass":"Amyloid Beta-directed Antibody Interactions","modality":"Monoclonal Antibody","drugClass":"Amyloid Beta-directed Antibody","explanation":"","oneSentence":"","technicalDetail":"Aduhelm is a monoclonal antibody that selectively binds to amyloid beta A4 protein, facilitating its clearance from the brain through a process involving the reticuloendothelial system and the blood-brain barrier."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Aducanumab","title":"Aducanumab","extract":"Aducanumab, sold under the brand name Aduhelm, is an anti-amyloid drug designed to treat Alzheimer's disease. It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai. Aducanumab is given via intravenous infusion.","wiki_history":"== History ==\nAducanumab was developed by Biogen Inc., which licensed the medication candidate from Neurimmune, who discovered it with the University of Zurich.\n\n===Clinical trials===\nInterim results from the second phase I study of the medication were reported in March 2015.\n\nA phase Ib study was published in August 2016, based on one year of \"monthly intravenous infusions\" of aducanumab, which brain scans to measure amyloid plaques.\n\nPhase III clinical trials were ongoing in September 2016, While imaging studies had shown that aducanumab did reduce amyloid plaque buildup, a surrogate endpoint for Alzheimer's treatment, it had not meaningfully met its primary endpoints with regards to cognitive function and mental decline.\n\nOn 22 October 2019, Biogen announced that it would be restarting the FDA approval process for aducanumab stating that analysis of a larger dataset from its Phase 3 trials showed that the drug reduced clinical decline in patients with early Alzheimer's disease when given at higher doses. In one trial, \"EMERGE\",(NCT02484547), an analysis split by dose indicated that high doses reduced rate of decline by 22% versus placebo. However, an identical trial, \"ENGAGE\", failed to replicate this, with a non-significant 2% reduction in decline compared to placebo. Researchers had theorized that the difference may have stemmed from a change in protocol which affected more of the participants of the later study EMERGE than the earlier ENGAGE study's participants. The FDA accepted Biogen's aducanumab Biologics License Application (BLA) on 7 August 2020 with a Priority Review.\n\n===FDA review and approval===\nIn November 2020, a panel of outside experts on the FDA's Peripheral and Central Nervous System Advisory Committee concluded that a pivotal study of aducanumab failed to show \"strong evidence\" that the medication worked, along with potential safety issues, and suggested that the FDA not approve aducanumab, citing questionable efficacy and multiple \"red flags\"","wiki_society_and_culture":"== Society and culture ==\n=== Efficacy ===\n\nThe June 2021 approval of the medication by the US Food and Drug Administration (FDA) was controversial because clinical trials gave conflicting results on its effectiveness. Specific criticisms of the approval included: insufficient evidence of efficacy, that the drug offers false hope, and that the high cost will adversely impact patient finances and Medicare budget. Soon after the approval was announced in early June 2021, three of the panelists who had voted against aducanumab's approval resigned in protest. One of the resigning panelists said that the FDA move was \"probably the worst drug approval decision in recent US history\".\n\n===Process concerns===\n\nPublic Citizen and the Institute for Clinical and Economic Review criticized the approval.\n\nSenator Joe Manchin heavily criticized the decision and said that the acting director of the FDA, Janet Woodcock, \"should be quickly replaced.\" According to The New York Times, the review process for the medication \"took several unusual turns, including a decision for the FDA to work far more closely with Biogen than is typical in a regulatory review.\" According to a 2022 report released by two House committees, FDA and Biogen worked in concert to receive accelerated approval at a cost to patients of $56,000 a year.\n\nFDA officials met with \"Biogen executives\" using \"back channels\" in the months prior to Aducanumab's FDA approval.\n\nIn July 2021, the FDA's acting commissioner, Janet Woodcock, requested that the Office of Inspector General, US Department of Health and Human Services conduct an independent review of interactions between FDA officials and Biogen representatives prior to the FDA's approval of aducanumab. It was reported that the OIG will also investigate the \"accelerated approval pathway, the regulatory mechanism\" the FDA used to approve Aducanumab in spite of \"conflicting data over whether it could actually slow Alzheimer's patients' mental decline.\"\n\nPatient advocac"},"commercial":{"launchDate":"2021","_launchSource":"DrugCentral (FDA 2021-06-07, BIOGEN INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5464","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ADUCANUMAB","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ADUCANUMAB","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Aducanumab","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T08:29:24.287864","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:24:17.958489+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"memantine","drugSlug":"memantine","fdaApproval":"2003-10-16","patentExpiry":"Sep 24, 2029","patentStatus":"Patent 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Volunteers","status":"COMPLETED","sponsor":"Biogen","startDate":"2021-06-30","conditions":["Healthy Volunteers"],"enrollment":30,"completionDate":"2021-10-01"},{"nctId":"NCT03639987","phase":"PHASE2","title":"A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities","status":"TERMINATED","sponsor":"Biogen","startDate":"2018-12-20","conditions":["Cognitive Dysfunction","Alzheimer's Disease"],"enrollment":52,"completionDate":"2019-07-30"},{"nctId":"NCT02484547","phase":"PHASE3","title":"221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease","status":"TERMINATED","sponsor":"Biogen","startDate":"2015-09-15","conditions":["Alzheimer's Disease"],"enrollment":1643,"completionDate":"2019-08-05"},{"nctId":"NCT02477800","phase":"PHASE3","title":"221AD301 Phase 3 Study of Aducanumab 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SOLUTION","route":"INTRAVENOUS","productName":"Aduhelm"}]},"crossReferences":{"MMSL":"347165","NDDF":"018764","UNII":"105J35OE21","VANDF":"4040592","INN_ID":"9838","RXNORM":"2557217","UMLSCUI":"C4043101","chemblId":"CHEMBL3039540","ChEMBL_ID":"CHEMBL3039540","KEGG_DRUG":"D10541","DRUGBANK_ID":"DB12274","SNOMEDCT_US":"1162583000","IUPHAR_LIGAND_ID":"8325","MESH_SUPPLEMENTAL_RECORD_UI":"C000600266"},"formularyStatus":[],"originalProduct":{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Biogen Inc.","brandName":"Aduhelm","isOriginal":true,"marketingStatus":"BLA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2021-","companyName":"Biogen","relationship":"Original Developer"}],"publicationCount":662,"therapeuticAreas":["Immunology"],"_revenueScrapedAt":"2026-03-31 10:32:55.513374+00","atcClassification":{"source":"DrugCentral","atcCode":"N06DX03","allCodes":["N06DX03"]},"biosimilarFilings":[],"originalDeveloper":"Biogen Inc","recentPublications":[{"date":"2026 Apr","pmid":"41885326","title":"Incidence of amyloid-related imaging abnormalities and health resource utilization in patients with Alzheimer disease receiving monoclonal antibody treatments: A real-world evidence study.","journal":"Journal of managed care & specialty pharmacy"},{"date":"2026 Mar 30","pmid":"41874248","title":"Drugs for dementia.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2026 Mar 16","pmid":"41837605","title":"Cost-effectiveness of traditional and novel neurotherapeutic agents for Alzheimer's disease: A systematic review.","journal":"Journal of Alzheimer's disease : JAD"},{"date":"2026 Feb 28","pmid":"41760995","title":"The evolving landscape of amyloid-targeting therapies in Alzheimer's disease: progress and challenges.","journal":"Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology"},{"date":"2026 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