View source for Lecanemab

{{Short description|Monoclonal antibody against amyloid beta}}
{{Use dmy dates|date=July 2024}}
{{cs1 config|name-list-style=vanc|display-authors=6}}
{{Infobox drug
| type = mab
| image =
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| alt               = 
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<!-- Monoclonal antibody data -->
| mab_type = mab
| source = zu
| target = [[Amyloid beta]]

<!-- Clinical data -->
| pronounce         = 
| tradename         = Leqembi
| Drugs.com         = {{drugs.com|monograph|lecanemab}}
| MedlinePlus       = 
| DailyMedID        = Lecanemab
| pregnancy_AU      = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment = 
| pregnancy_category = 
| routes_of_administration = [[Intravenous]]
| class             = 
| ATC_prefix        = N06
| ATC_suffix        = DX04
| ATC_supplemental  = 
| biosimilars       = 

<!-- Legal status -->
| legal_AU          = S4
| legal_AU_comment  = <ref>{{cite web | title=Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 | website=Federal Register of Legislation | date=30 May 2024 | url=https://www.legislation.gov.au/F2024L00589/asmade/text | access-date=10 June 2024 | archive-date=10 June 2024 | archive-url=https://web.archive.org/web/20240610054546/https://www.legislation.gov.au/F2024L00589/asmade/text | url-status=live }}</ref>
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| legal_CA          = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
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| legal_DE          = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment  = 
| legal_NZ          = <!-- Class A, B, C -->
| legal_NZ_comment  = 
| legal_UK          = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment  = 
| legal_US          = Rx-only
| legal_US_comment  = <ref name="Leqembi FDA label" />
| legal_EU          = 
| legal_EU_comment  = 
| legal_UN          = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment  = 
| legal_status      = <!-- For countries not listed above -->

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<!-- Identifiers -->
| CAS_number = 1260393-98-3
| CAS_supplemental  = 
| PubChem =  
| IUPHAR_ligand     = 
| DrugBank =  DB14580
| ChemSpiderID = none
| UNII = 12PYH0FTU9
| KEGG = D11678 
| ChEBI             = 
| ChEMBL            = 
| NIAID_ChemDB      = 
| PDB_ligand        = 
| synonyms = BAN2401, lecanemab-irmb

<!-- Chemical and physical data -->
| IUPAC_name        = 
| C = 6544 | H = 10088 | N = 1744 | O = 2032 | S = 46
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}}

'''Lecanemab''', sold under the brand name '''Leqembi''', is a [[monoclonal antibody]] medication used for the treatment of [[Alzheimer's disease]].<ref name="Leqembi FDA label">{{cite web |date=11 January 2023 |title=Leqembi – lecanemab injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d1ff786-e577-410a-a273-c4d7d0e4e975 |url-status=live |archive-url=https://web.archive.org/web/20230115032033/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d1ff786-e577-410a-a273-c4d7d0e4e975 |archive-date=15 January 2023 |access-date=21 January 2023 |website=DailyMed}}</ref><ref name="FDA PR 20230106" /> Lecanemab is an [[amyloid beta]]-directed antibody.<ref name="Leqembi FDA label" /> It is given via [[intravenous infusion]] to patients with [[mild cognitive impairment]] or mild dementia.<ref name="Leqembi FDA label" /> In clinical trials, it demonstrated modest efficacy in reducing relative cognitive decline compared to placebo.<ref>{{Cite journal |last=Kwon |first=Diana |date=2024-08-22 |title=Debate rages over Alzheimer's drug lecanemab as UK limits approval |url=https://www.nature.com/articles/d41586-024-02720-y |journal=Nature |language=en |doi=10.1038/d41586-024-02720-y}}</ref> The most common side effects of lecanemab include headache, infusion-related reactions, and [[amyloid-related imaging abnormalities]], a side effect known to occur with the class of antibodies targeting amyloid.<ref name="FDA PR 20230706" />

Lecanemab was jointly developed by [[Eisai (company)|Eisai]] and [[Biogen]]. It was granted [[accelerated approval]] for medical use in the United States in January 2023,<ref>{{cite web | title=Drug Approval Package: Leqembi | website=U.S. [[Food and Drug Administration]] (FDA) | date=6 February 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761269Orig1s000TOC.cfm | access-date=8 July 2023 | archive-date=9 July 2023 | archive-url=https://web.archive.org/web/20230709043242/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761269Orig1s000TOC.cfm | url-status=live }}</ref> and fully approved by the FDA in July 2023.<ref name="FDA PR 20230106">{{cite press release | title=FDA Grants Accelerated Approval for Alzheimer's Disease Treatment | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=6 January 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment | access-date=7 January 2023 | archive-date=7 January 2023 | archive-url=https://web.archive.org/web/20230107000220/https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment | url-status=live }} {{PD-notice}}</ref><ref>{{Cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2023/761269Orig1s000SumR.pdf |title=Lecanemab Summary Review | work = Center for Drug Evaluation and Research (CDER) | publisher = U.S. [[Food and Drug Administration]] (FDA) |access-date=7 January 2023 |archive-date=7 January 2023 |archive-url=https://web.archive.org/web/20230107005316/https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2023/761269Orig1s000SumR.pdf |url-status=live }}</ref> Lecanemab was priced at $26,500 per year in the United States.<ref>{{Cite web |title=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 |url=https://www.eisai.com/news/2023/news202302.html |access-date=2024-09-19 |website=Eisai Co., Ltd. |language=en}}</ref> The [[European Medicines Agency]] ruled against approving the drug.<ref>{{cite web |title=First drug to slow Alzheimer's too costly for NHS|date=22 August 2024 |url=https://www.bbc.co.uk/news/articles/c75nry66y52o}}</ref> In Great Britain, the drug was approved but will not be covered by the English [[NHS]] due to its unfavorable benefit–cost ratio.

== Medical uses ==
Lecanemab is [[indicated]] for the treatment of Alzheimer's disease in patients who have mild cognitive impairment or mild dementia, but not in patients who already have moderate or severe dementia.<ref name="Leqembi FDA label" /><ref name="FDA PR 20230106" /><ref name="FDA PR 20230706" />

=== Efficacy ===

In a [[Phase 3 clinical testing|phase 3]] clinical trial of 1,795 patients aged 50 to 90 years old with early-stage Alzheimer’s disease, lecanemab slowed clinical decline by 27% after 18 months of treatment compared with those who received a placebo.<ref>{{Cite web |title=Lecanemab, the New Alzheimer's Treatment: 3 Things To Know |url=https://www.yalemedicine.org/news/lecanemab-leqembi-new-alzheimers-drug |url-status=live |archive-url=https://web.archive.org/web/20231207180741/https://www.yalemedicine.org/news/lecanemab-leqembi-new-alzheimers-drug |archive-date=7 December 2023 |access-date=7 December 2023 |website=Yale Medicine}}</ref><ref name="van Dyck Swanson Aisen Bateman 2023 pp. 9–21">{{cite journal |vauthors=van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T |date=January 2023 |title=Lecanemab in Early Alzheimer's Disease |journal=The New England Journal of Medicine |publisher=Massachusetts Medical Society |volume=388 |issue=1 |pages=9–21 |doi=10.1056/nejmoa2212948 |pmid=36449413 |s2cid=254094094 |doi-access=free}}</ref> The mean [[Clinical Dementia Rating|CDR-SOB]] score at baseline was approximately 3.2 among the study population, and the mean change from baseline after 18 months was +1.21 with lecanemab and +1.66 with placebo. (For the comparison, CDR-SOB score is 0 for the	Normal level, 0.5–2.5 for Questionable impairment, 3.0–4.0 for	Very mild dementia, 4.5–9.0 for Mild dementia, 9.5–15.5 for Moderate dementia, and 16.0–18.0	for Severe dementia.)<ref>{{cite journal |vauthors=O'Bryant SE, Waring SC, Cullum CM, Hall J, Lacritz L, Massman PJ, Lupo PJ, Reisch JS, Doody R |date=August 2008 |title=Staging dementia using Clinical Dementia Rating Scale Sum of Boxes scores: a Texas Alzheimer's research consortium study |journal=Archives of Neurology |volume=65 |issue=8 |pages=1091–1095 |doi=10.1001/archneur.65.8.1091 |pmc=3409562 |pmid=18695059}}</ref> The authors concluded "Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events."<ref name="van Dyck Swanson Aisen Bateman 2023 pp. 9–21" />

== Adverse effects ==
Lecanemab may cause [[amyloid-related imaging abnormalities]] (ARIA). ARIA is often [[asymptomatic]], but serious and life-threatening events rarely may occur. ARIA most commonly presents as temporary swelling of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure.<ref name="FDA PR 20230106" /><ref name="FDA PR 20230706" /> Compared to placebo, all doses of the drug caused accelerated brain shrinkage.<ref>{{cite journal | vauthors = Liu KY, Villain N, Ayton S, Ackley SF, Planche V, Howard R, Thambisetty M | title = Key questions for the evaluation of anti-amyloid immunotherapies for Alzheimer's disease | journal = Brain Communications | volume = 5 | issue = 3 | pages = fcad175 | date = 2 May 2023 | pmid = 37389302 | pmc = 10306158 | doi = 10.1093/braincomms/fcad175 }}</ref>

== Pharmacology ==
=== Mechanism of action ===
{{Main|Biochemistry of Alzheimer's disease#Amyloid hypothesis}}
[[File:Images large 10.1177 03946320231209839-fig1.jpg|thumb|upright=1.2|Mechanism of action of lecanemab]]
Lecanemab is a [[monoclonal antibody]] consisting of the [[Humanized antibody|humanized]] version<ref name="Lannfelt_2014">{{cite journal |vauthors=Lannfelt L, Möller C, Basun H, Osswald G, Sehlin D, Satlin A, Logovinsky V, Gellerfors P |date=2014 |title=Perspectives on future Alzheimer therapies: amyloid-β protofibrils – a new target for immunotherapy with BAN2401 in Alzheimer's disease |journal=Alzheimer's Research & Therapy |volume=6 |issue=2 |pages=16 |doi=10.1186/alzrt246 |pmc=4054967 |pmid=25031633 |doi-access=free}}</ref> of a mouse antibody, mAb158, that recognizes [[fibril|protofibrils]] and prevents [[amyloid beta]] deposition in [[animal model]]s of Alzheimer's disease.<ref name="Söllvander_2018">{{cite journal | vauthors = Söllvander S, Nikitidou E, Gallasch L, Zyśk M, Söderberg L, Sehlin D, Lannfelt L, Erlandsson A | title = The Aβ protofibril selective antibody mAb158 prevents accumulation of Aβ in astrocytes and rescues neurons from Aβ-induced cell death | journal = Journal of Neuroinflammation | volume = 15 | issue = 1 | pages = 98 | date = March 2018 | pmid = 29592816 | pmc = 5875007 | doi = 10.1186/s12974-018-1134-4 | doi-access = free }}</ref>

== History ==
In July 2022, the US [[Food and Drug Administration]] (FDA) accepted an application for accelerated approval for lecanemab.<ref name="Biogen-Sep22" />

In September 2022, [[Biogen]] announced<ref name="Biogen-Sep22">{{cite press release |url=https://investors.biogen.com/news-releases/news-release-details/lecanemab-confirmatory-phase-3-clarity-ad-study-met-primary |title=Lecanemab Confirmatory Phase 3 Clarity Ad Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction of Clinical Decline in Large Global Clinical Study of 1,795 Participants With Early Alzheimer's Disease |publisher=Biogen |access-date=28 September 2022 |date=27 September 2022 |archive-date=27 September 2022 |archive-url=https://web.archive.org/web/20220927233155/https://investors.biogen.com/news-releases/news-release-details/lecanemab-confirmatory-phase-3-clarity-ad-study-met-primary |url-status=live }}</ref><ref>{{cite news |vauthors=Robbins R, Belluck P |url=https://www.nytimes.com/2022/09/27/business/alzheimers-drug-biogen-lecanemab.html |title=Alzheimer's Drug Slows Cognitive Decline in Key Study |work=[[The New York Times]] |date=27 September 2022 |access-date=28 September 2022 |archive-date=28 September 2022 |archive-url=https://web.archive.org/web/20220928021026/https://www.nytimes.com/2022/09/27/business/alzheimers-drug-biogen-lecanemab.html |url-status=live }}</ref> positive results from an ongoing [[phase III clinical trial]].<ref>{{cite web |url=https://clinicaltrials.gov/ct2/show/NCT03887455 |title=A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD) |date=11 July 2022 |publisher=ClinicalTrials.gov |access-date=28 September 2022 |archive-date=28 September 2022 |archive-url=https://web.archive.org/web/20220928145815/https://clinicaltrials.gov/ct2/show/NCT03887455 |url-status=live }}</ref><ref>{{cite web | vauthors = Sample I |url=https://www.theguardian.com/society/2022/nov/22/treatment-for-alzheimers-lecanemab-dementia-research |title='This looks like the real deal': Are we inching closer to a treatment for Alzheimer's? |website=[[The Guardian]] |date=22 November 2022 | archive-date=10 January 2023 |archive-url= https://web.archive.org/web/20230110050040/https://www.theguardian.com/society/2022/nov/22/treatment-for-alzheimers-lecanemab-dementia-research |url-status=live }}</ref>

In November 2022, it was announced that the drug was a success in clinical trials, and exceeded its goal in reaching primary endpoints.<ref>{{cite news | vauthors=Gallagher J |url=https://www.bbc.com/news/health-63749586 |title=Alzheimer's drug lecanemab hailed as momentous breakthrough | publisher=BBC News Online | date=30 November 2022 |access-date=30 November 2022 |archive-date=2 December 2022 |archive-url=https://web.archive.org/web/20221202053951/https://www.bbc.com/news/health-63749586 |url-status=live }}</ref>
[[File:Amyloid-plaque formation-big.jpg|thumb|upright=2|Enzymes act on the APP (Amyloid precursor protein) and cut it into fragments of protein, one of which is called beta-amyloid and its crucial in the formation of senile plaques in Alzheimer. Image created in 2008.]]
The efficacy of lecanemab was evaluated in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 participants with Alzheimer's disease.<ref name="FDA PR 20230106" /> Treatment was initiated in participants whose disease was in the stage of mild [[Cognitive deficit|cognitive impairment]] or mild [[dementia]] and who had confirmed presence of amyloid beta pathology.<ref name="FDA PR 20230106" /> Participants receiving the treatment showed significant dose- and time-dependent reduction of amyloid beta plaque: Those receiving the approved dose of lecanemab, 10&nbsp;milligrams/kilogram every two weeks, had a statistically significant reduction in brain amyloid plaque from baseline to week 79 compared with those receiving a placebo, who had no reduction of amyloid beta plaque.<ref name="FDA PR 20230106" />&nbsp;

The FDA approved lecanemab in January 2023, via the [[Accelerated approval (FDA)|accelerated approval]] pathway for the treatment of Alzheimer's disease.<ref name="FDA PR 20230106" />&nbsp;The FDA granted the application for lecanemab [[Fast track (FDA)|fast track]], [[priority review]], and [[breakthrough therapy]] designations.<ref name="FDA PR 20230106" /> The approval of Leqembi was granted to [[Eisai (company)|Eisai R&D Management Co., Ltd]].<ref name="FDA PR 20230106" /> In July 2023, the FDA converted lecanemab to traditional approval.<ref name="FDA PR 20230706" />

Efficacy of lecanemab was evaluated using the results of Study 301 (CLARITY AD), a phase III randomized, controlled clinical trial.<ref name="FDA PR 20230706" /> Study 301 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that enrolled 1,795 participants with Alzheimer's disease.<ref name="FDA PR 20230706" /> Treatment was initiated in participants with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology.<ref name="FDA PR 20230706" /> Participants were randomized in a 1:1 ratio to receive placebo or lecanemab at a dose of 10 milligrams (mg)/kilograms (kg), once every two weeks.<ref name="FDA PR 20230706" /> Lecanemab demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint, the [[Clinical Dementia Rating]] Scale Sum of Boxes score, compared to placebo.<ref name="FDA PR 20230706" /> Statistically significant differences between treatment groups were also demonstrated on all secondary endpoints, which included the [[Alzheimer's Disease Assessment Scale-Cognitive Subscale|Alzheimer's Disease Assessment Scale Cognitive Subscale]] 14, and the [[Alzheimer's Disease Cooperative Study]]–Activities of Daily Living Scale for Mild Cognitive Impairment.<ref name="FDA PR 20230706" />

== Society and culture ==

=== Legal status ===

==== United States ====
In January 2023, the FDA granted accelerated approval for lecanemab.<ref name="FDA PR 20230106" /><ref>{{cite news |date=6 January 2023 |title=Alzheimer's drug lecanemab receives accelerated approval amid safety concerns |publisher=[[CNN]] |url=https://www.cnn.com/2023/01/06/health/lecanemab-fda-approval/index.html |url-status=live |access-date=11 January 2023 |archive-url=https://web.archive.org/web/20230106200542/https://www.cnn.com/2023/01/06/health/lecanemab-fda-approval/index.html |archive-date=6 January 2023 |vauthors=Howard J, Goodman B}}</ref> In July 2023, the FDA converted lecanemab to traditional approval.<ref name="FDA PR 20230706">{{cite press release | title=FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval | website=U.S. [[Food and Drug Administration]] (FDA) | date=6 July 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval | access-date=6 July 2023 | archive-date=6 July 2023 | archive-url=https://web.archive.org/web/20230706210946/https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval | url-status=live }} {{PD-notice}}</ref>

==== European Union ====
In July 2024, the [[European Medicines Agency]] (EMA) recommended the refusal of the marketing authorization for lecanemab. The manufacturer requested re-examination.<ref name="Leqembi EPAR">{{cite web |date=2024-08-05 |title=Leqembi |url=https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi |access-date=2024-08-22 |website=European Medicines Agency}}</ref>

==== United Kingdom ====
In August 2024, the [[Medicines and Healthcare products Regulatory Agency]] (MHRA) granted marketing authorisation for England, Scotland and Wales. It may not be used in patients with two copies of the [[ApoE4]] allele. Statistically, these patients develop Alzheimer's disease more frequently and earlier, but also have a particularly high incidence of ARIA when treated with lecanemab. According to the MHRA, the risk outweighs the benefit for these people and genetic testing is recommended before starting treatment.<ref name=":1">{{Cite web |last=Walsh |first=Fergus |date=2024-08-22 |title=Lecanemab: First drug to slow Alzheimer's too costly for NHS |url=https://www.bbc.com/news/articles/c75nry66y52o |access-date=2024-08-23 |website=www.bbc.com |language=en-GB}}</ref><ref name=":2">{{Cite web |date=2024-08-22 |title=Lecanemab licensed for adult patients in the early stages of Alzheimer's disease |url=https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease |access-date=2024-08-23 |website=[[Medicines and Healthcare products Regulatory Agency]] |language=en}}</ref><ref name=":3">{{Cite web |last=Taylor |first=Emma |date=2024-08-22 |title=New Alzheimer's treatment, lecanemab, makes the headlines: what's next? |url=https://www.alzheimersresearchuk.org/news/new-alzheimers-treatment-lecanemab-makes-the-headlines-whats-next/ |access-date=2024-08-23 |website=[[Alzheimer's Research UK]] |language=en-GB}}</ref>

The English branch of the [[National Health Service]] (NHS) announced it would not cover the costs of treatment, as according to draft guidance from the [[National Institute for Health and Care Excellence]] (NICE), the small benefit does not justify the cost of treatment.<ref name=":1" /><ref name=":2" /><ref name=":3" />

Drugs in [[Northern Ireland]] are regulated by the EMA after Brexit in accordance with the [[Northern Ireland Protocol]].<ref name=":3" />

=== Reception ===
In October 2023, lecanemab was designated as a Do Not Use drug by [[Public Citizen]]'s Health Research Group.<ref name=":0">{{Cite news |date=1 October 2023 |title="Lecanemab for Alzheimer's Disease: Do Not Use" |volume=29 |work=Worst Pills, Best Pills News |publisher=[[Public Citizen]] |issue=10}}</ref> It had urged the FDA not to approve it, arguing that there were serious safety concerns and very small treatment benefits. <ref name=":0" />

=== Economics ===
{{also|Aducanumab#Economics and cost}}<!--closely related, with overlapping factors and analysis-->
Lecanemab pricing is {{US$|26,500}} per year,<ref>{{cite press release | title=Eisai's Approach To U.S. Pricing For Leqembi (Lecanemab), a Treatment For Early Alzheimer's Disease, Sets Forth Our Concept Of "Societal Value Of Medicine" In Relation To "Price Of Medicine" | publisher=Eisai Inc. | via=PR Newswire | date=6 January 2023 | url=https://www.prnewswire.com/news-releases/eisais-approach-to-us-pricing-for-leqembi-lecanemab-a-treatment-for-early-alzheimers-disease-sets-forth-our-concept-of-societal-value-of-medicine-in-relation-to-price-of-medicine-301715694.html | access-date=7 January 2023 | archive-date=7 January 2023 | archive-url=https://web.archive.org/web/20230107003039/https://www.prnewswire.com/news-releases/eisais-approach-to-us-pricing-for-leqembi-lecanemab-a-treatment-for-early-alzheimers-disease-sets-forth-our-concept-of-societal-value-of-medicine-in-relation-to-price-of-medicine-301715694.html | url-status=live }}</ref> with a company-estimated "per-patient societal value" of {{US$|37,600}}.<ref name="Bell_2023" /> However, cost-effectiveness analysis by the [[Institute for Clinical and Economic Review]] (ICER) concluded that a broad range of $8,900 to $21,500 would be appropriate.<ref name="Institute for Clinical and Economic Review_2023" /> According to an estimate by the manufacturer, Eisai, about 85% of eligible early-Alzheimer's patients in the United States are covered by [[Medicare (United States)|Medicare]].<ref name="Bell_2023">{{cite news | vauthors = Bell J |date=6 February 2023 |title=Eisai gives first glimpse into Alzheimer's drug launch |work=BiopharmaDive |url=https://www.biopharmadive.com/news/eisai-alzheimers-leqembi-launch-earnings/642067/ |access-date=11 February 2023 |archive-date=12 February 2023 |archive-url=https://web.archive.org/web/20230212021851/https://www.biopharmadive.com/news/eisai-alzheimers-leqembi-launch-earnings/642067/ |url-status=live }}</ref>

After reviewing the clinical evidence and considering the treatments' other potential benefits, disadvantages, and contextual considerations noted above, the California Technology Assessment Forum unanimously concluded that lecanemab at its current pricing represents "low" long term value of money.<ref name="Institute for Clinical and Economic Review_2023" /> At lecanemab's current net price, approximately 5% of the 1.4 million US patients eligible for Alzheimer's disease treatment that targets beta-amyloid could be treated within five years without crossing the ICER potential budget impact threshold of $777 million per year.<ref name="Institute for Clinical and Economic Review_2023" /> As a result, ICER issued an access and affordability alert for lecanemab in the management of Alzheimer's disease. This alert indicates that the health care costs of the treatment might stress the health system in the short term, resulting in the displacement of other services and a rapid increase in insurance costs.<ref name="Institute for Clinical and Economic Review_2023">{{cite press release | title=ICER Publishes Final Evidence Report on Lecanemab for Alzheimer's Disease | publisher=Institute for Clinical and Economic Review | date=17 April 2023 | url=https://icer.org/news-insights/press-releases/icer-publishes-final-evidence-report-on-lecanemab-for-alzheimers-disease/ | access-date=7 May 2023 | archive-date=7 May 2023 | archive-url=https://web.archive.org/web/20230507225116/https://icer.org/news-insights/press-releases/icer-publishes-final-evidence-report-on-lecanemab-for-alzheimers-disease/ | url-status=live }}</ref>

=== Names ===
Lecanemab is the [[international nonproprietary name]].<ref name=WHORecList84>{{cite journal | vauthors = ((World Health Organization)) | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84 | journal = WHO Drug Information | volume = 34 | issue = 3 | year = 2020 | hdl = 10665/340680 | hdl-access = free | author-link = World Health Organization }}</ref>

== Research ==
Lecanemab was jointly developed by the companies [[Eisai (company)|Eisai]] and [[Biogen]] and is in [[clinical trial]]s for the treatment of [[Alzheimer's disease]].<ref>{{ClinicalTrialsGov|NCT01767311|Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease}}</ref>

It has shown statistically significant but minor effectiveness, with studies suggesting a modest decrease in [[cognitive decline]] in Alzheimer's participants compared with a [[control group]] given a [[placebo]] instead.<ref>{{cite web |vauthors=Devlin H |date=28 September 2022 |work=[[The Guardian]] |title=Success of experimental Alzheimer's drug hailed as 'historic moment' |url=https://www.theguardian.com/society/2022/sep/28/alzheimers-disease-progression-slowed-by-new-drug-lecanemab |archive-url=https://web.archive.org/web/20220928185834/https://www.theguardian.com/society/2022/sep/28/alzheimers-disease-progression-slowed-by-new-drug-lecanemab |archive-date=28 September 2022 |url-status=live}}</ref>

According to a phase III clinical trial (n = 1795), lecanemab has been associated with both ARIA-E ([[cerebral edema]]) and ARIA-H (microhaemorrhages, or small [[haemorrhages]], and [[hemosiderosis]]) sub-types.<ref name="van Dyck Swanson Aisen Bateman 2023 pp. 9–21" /> Mild to moderate infusion-related reactions may also occur.<ref name="van Dyck Swanson Aisen Bateman 2023 pp. 9–21" />

== References ==
{{Reflist}}

== Further reading ==
{{refbegin}}
* {{cite journal | vauthors = Tolar M, Abushakra S, Hey JA, Porsteinsson A, Sabbagh M | title = Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval | journal = Alzheimer's Research & Therapy | volume = 12 | issue = 1 | pages = 95 | date = August 2020 | pmid = 32787971 | pmc = 7424995 | doi = 10.1186/s13195-020-00663-w | title-link = doi | doi-access = free }}
* {{cite journal | vauthors = Villain N, Planche V, Levy R | title = High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 1: Meta-analysis and review of efficacy and safety data, and medico-economical aspects | journal = Revue Neurologique | volume = 178 | issue = 10 | pages = 1011–1030 | date = December 2022 | pmid = 36184326 | doi = 10.1016/j.neurol.2022.06.012 | title-link = doi | doi-access = free }}
{{refend}}

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