Alzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab

Zacks06-12

The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to Biogen BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States ...

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Two products on the market should accelerate uptake as Eisai, Lilly and Biogen will invest in educating patients and physicians and building the necessary infrastructure to boost sales. The FDA committee’s endorsement of donanemab, in a way, reflects FDA’s optimistic approach for Aβ targeting Alzheimer’s treatments which have an acceptable benefit-risk profile.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0466842654.USD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"A\" (USD) ACC","LU0097036916.USD":"贝莱德美国增长A2 USD","LU0882574055.USD":"富达全球健康医疗A ACC","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","LU0122379950.USD":"贝莱德世界健康科学A2","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU1064131342.USD":"Fullerton Lux Funds - Global Absolute Alpha A Acc USD","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","LU0882574139.USD":"富达环球消费行业基金A ACC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","PRTA":"Prothena Corporation plc","ARIA":"阿里阿德","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","LU2491049909.HKD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (HKD) ACC","LU0079474960.USD":"联博美国增长基金A","LU2237443382.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA USD","LU2491050071.SGD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (SGDHDG) ACC","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","LU2237443549.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA SGD-H","LU1623119135.USD":"Natixis Mirova Global Sustainable Equity R-NPF/A USD","LU2491050154.USD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (USD) ACC","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQ \"AU\" (USD) ACC","LU1712237335.SGD":"Natixis Mirova Global Sustainable Equity H-R-NPF/A SGD","LU2265009873.SGD":"Eastspring Investments - Global Growth Equity AS SGD-H","LU2237443622.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc USD","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","ACIU":"AC Immune SA","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU2237443978.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc SGD-H","IE00B19Z9P08.USD":"LEGG MASON CLEARBRIDGE US AGGRESSIVE GROWTH \"A\" (USD) INC","BK4585":"ETF&股票定投概念","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","BK4534":"瑞士信贷持仓","LU1804176565.USD":"EASTSPRING INV GLOBAL GROWTH EQUITY \"A\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","LU0058720904.USD":"联博国际健康护理基金A","BK4007":"制药","LU2264538146.SGD":"Fullerton Lux Funds - Global Absolute Alpha A Acc SGD","BIIB":"渤健公司","LLY":"礼来"},"translate_title":"FDA小组认可礼来公司的Donanemab，阿尔茨海默病成为焦点","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ARIA":1,"PRTA":1,"LLY":1,"ACIU":1,"BIIB":0.9},"content_text":"The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to Biogen BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States to reduce the cognitive decline associated with early Alzheimer’s disease.\nOn Jun 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 11-0, unanimously recommending the approval of Eli Lilly’s LLY Alzheimer's disease drug, donanemab.\nThe committee said that data from clinical studies on donanemab demonstrated substantial evidence of efficacy and a clinically meaningful slowdown in disease progression for early symptomatic Alzheimer’s patients. Overall, the committee voted that the benefits of donanemab outweighed the risks despite some safety concerns. Lilly is seeking approval for donanemab for the treatment of patients with mild Alzheimer’s disease.\nAlzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Both Leqembi and donanemab are Aβ targeting therapies. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease. However, anti-amyloid antibodies can cause a brain swelling side effect called amyloid-related imaging abnormalities (ARIA). In clinical studies, ARIA-E (ARIA - edema/effusions) was observed in 24% and ARIA-H (ARIA-hemorrhage/hemosiderin deposition) in 31% of donanemab-treated patients. However, to Lilly’s advantage, the panel said such risks could be addressed by “appropriate labeling and management.”\nMost analysts are now expecting donanemab to gain FDA approval with a broad label and a warning for ARIA. Leqembi’s label also has a similar warning for ARIA. A PDUFA date, however, has not been scheduled by the FDA for a decision on donanemab after the original decision was delayed for the need of the advisory meeting.\nUntil Leqembi was approved, the drugs available in the market just treated the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease despite making significant investments. Biogen/Eisai’s controversial medicine, Aduhelm, was approved by the FDA in 2021. However, in January 2024, Biogen discontinued the development and commercialization of Aduhelm as the drug failed to generate any significant sales due to a lack of access to Medicare beneficiaries.\nHowever, with donanemab just one step away from approval, the Alzheimer’s market could soon get two drugs. Two products on the market should accelerate uptake as Eisai, Lilly and Biogen will invest in educating patients and physicians and building the necessary infrastructure to boost sales. The FDA committee’s endorsement of donanemab, in a way, reflects FDA’s optimistic approach for Aβ targeting Alzheimer’s treatments which have an acceptable benefit-risk profile.\nBiogen/Eisai are also quite bullish on Leqembi’s progress. Though Leqembi has had a lackluster launch, Biogen and Eisai expect the sales of Leqembi to grow in 2024, with signs of acceleration seen in the first quarter. Biogen and Eisai believe it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease.\nThe Centers for Medicare & Medicaid Services has also granted broad reimbursement to Leqembi under Medicare plans. Leqembi is also approved in China and Japan, which could bring in additional sales going forward. Regulatory applications seeking the approval of Leqembi are under review in Europe.\nProthena Corporation PRTA, AC Immune ACIU and Cassava Sciences are also developing therapies for Alzheimer's disease. Prothena’s Alzheimer’s candidate is PRX012, a next-generation subcutaneous antibody targeting a key epitope at the N-terminus of Aβ. PRX012 is in early-stage development. The FDA has granted Fast Track Designation to PRX012 for the treatment of Alzheimer's disease. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.\nAC Immune is conducting a phase III program consisting of two global studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. Top-line data from the 52-week RETHINK-ALZ study is expected by the end of 2024, while that from the second study, the 76-week REFOCUS-ALZ study, is expected by mid-year 2025.\nThough there are some challenges and administrative hurdles associated with the marketing of Alzheimer’s drugs, the entry of additional players should further raise disease awareness and benefit the Alzheimer’s market as a whole.\nLilly and Biogen carry a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nBiogen Inc. (BIIB) : Free Stock Analysis Report\nEli Lilly and Company (LLY) : Free Stock Analysis Report\nProthena Corporation plc (PRTA) : Free Stock Analysis Report\nAC Immune (ACIU) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":1,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.25.1","shortVersion":"4.25.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2442156671"}