Author: Sensi, Stefano L ; Kepp, Kasper P ; Høilund-Carlsen, Poul F ; Alavi, Abass ; Vissel, Bryce ; Costa, Tommaso ; Barrio, Jorge R ; Robakis, Nikolaos K ; Neve, Rachael L ; Herrup, Karl ; Revheim, Mona-Elisabeth ; Perry, George ; Castellani, Rudolph J

Based on "reducing amyloid plaques in the brain", the U.S. Food and Drug Administration has granted accelerated and full approval for two monoclonal anti-Alzheimer's antibodies, aducanumab and lecanemab, respectively. Approval of a third antibody, donanemab, is pending. Moreover, lecanemab and donanemab are claimed to cause delay in the cognitive decline that characterizes the disease. We believe that these findings are subject to misinterpretation and statistical bias. Donanemab is claimed to cause removal of up to 86 % of cerebral amyloid and 36 % delay in cognitive decline compared to placebo. In reality, these are very small changes on an absolute scale and arguably less than what can be achieved with cholinesterase inhibitor/memantine therapy. Moreover, the "removal" of amyloid, based on the reduced accumulation of amyloid-PET tracer, most likely also reflects therapy-related tissue damage. This would also correlate with the minimal clinical effect, the increased frequency of amyloid-related imaging abnormalities, and the accelerated loss of brain volume in treated compared to placebo patients observed with these antibodies. We recommend halting approvals of anti-AD antibodies until these issues are fully understood to ensure that antibody treatment does not cause more harm than benefit to patients.

01 Jul 2008·Neuroscience lettersQ4 · MEDICINE

Bis(7)-tacrine, a promising anti-Alzheimer's dimer, affords dose- and time-dependent neuroprotection against transient focal cerebral ischemia

Q4 · MEDICINE

Article

Author: Yuanping Pang ; Wenming Li ; Yuming Zhao ; Dickson T.K. Lau ; Nelson T.K. Lee ; Yifan Han ; Xuejun Zhang ; Peter C.Y. Chow ; Xiaoliang Wang

Bis(7)-tacrine, a promising anti-Alzheimer's dimer, has been shown to have multiple neuroprotective activities in vitro. Here, we investigate whether bis(7)-tacrine attenuates focal cerebral ischemic impairment in vivo. Cerebral ischemia was induced in Sprague-Dawley rats by transient (2h) middle cerebral artery occlusion (MCAO) followed by 24h of reperfusion. Bis(7)-tacrine administered intraperitoneally 15 min after ischemia dose-dependently improved neurological behavior deficits and reduced both cerebral infarct volume and edema. The TUNEL staining assay showed that bis(7)-tacrine attenuated neuronal apoptosis in the penumbral region. Compared with that for memantine, a moderately effective N-methyl-d-aspartate (NMDA) receptor antagonist with a similar affinity and potency to bis(7)-tacrine in blocking NMDA receptors, the therapeutic window for bis(7)-tacrine was wider and lasted up to 6h after the onset of ischemia. Bis(7)-tacrine did not affect physiological parameters or regional cerebral blood flow during either the occlusion period or the early reperfusion stage. In conclusion, bis(7)-tacrine dose- and time-dependently protected against acute focal cerebral ischemic insults, possibly through the drug's anti-apoptotic effects during multiple events in the ischemic cascade.

01 Jan 2008·Nihon yakurigaku zasshi. Folia pharmacologica Japonica

Neurotoxicity of amyloid β proteins

Review

Author: Inagaki, Chiyoko ; Kigatawa, Kaori ; Nakayama, Yasuhisa ; Hattori, Naoki

A review on the mol. mechanism of the formation of amyloid β protein (Aβ), the origin of intracellular Aβ accumulation in neuronal cells, neuronal injuries by extracellular Aβ, neuronal injuries by intracellular Aβ, inhibition of PI4K and Cl^- pump activity by Aβ, enhancement of neurotoxicity of glutamate by elevated [Cl^-]_i, and development of anti-Alzheimer's agents which inhibit [Cl^-]_i increase and prevent neurotoxicity of glutamate.

News (Medical) associated with Alzheimer's(Chimerna Therapeutics)

05 Nov 2024

·www.businesswire.com

Alzheimer's Drugs Global Market Overview 2024 - 9.9% CAGR Forecast During 2024-2030, with Market Set to Reach a Projected US$9.2 Billion by 2030 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Alzheimer's Drugs - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. The global market for Alzheimer's Drugs is forecast to maintain a robust CAGR of 9.9% during the 2024-2030 analysis period, to reach a projected US$9.2 billion by 2030 from an estimated US$5.2 billion in 2024. The rising prevalence of Alzheimer's disease, driven mainly by the aging population, is leading to the expansion of the Alzheimer's drugs market. With the increase in life expectancy, especially in developed countries, there is a growing number of people at risk for Alzheimer's disease, leading to a larger group of potential patients. Innovations in drug development, such as medications aimed at the root cause of illnesses, combined with increased awareness and early diagnoses, further drive this market growth. Additionally, governments and healthcare organizations are boosting their financial support for Alzheimer's research, accelerating the development of new drugs, and expediting regulatory approvals. However, several factors hinder market growth, including the high cost and complexity of drug development, frequent clinical trial failures, patent expirations, limited awareness of Alzheimer's in underdeveloped countries, and the high cost of treatments, which restrict accessibility and market potential. Alzheimer's Drugs Regional Market Analysis North America leads the Alzheimer's drugs market with an estimated share of 38.9% in 2024, driven by a high prevalence of the disease, recent drug approvals, and advanced healthcare systems. The region benefits from major pharmaceutical companies conducting research and clinical trials alongside an aging population. Conversely, the Asia Pacific region is projected to be the fastest-growing market, with a CAGR of 11.5% during the analysis period 2024-2030. This growth is fueled by the rising prevalence of Alzheimer's, increased awareness, and a focus on unmet medical needs, particularly in countries like China and India. The region's less stringent regulations make it an attractive location for clinical trials and drug development. Alzheimer's Drugs Market Analysis by Drug Class Cholinesterase inhibitors dominate the Alzheimer's drugs market, holding an estimated 42.3% share in 2024, driven by their effectiveness in treating mild-to-moderate Alzheimer's through increased acetylcholine levels. Their oral administration and proven efficacy solidify their role as primary treatment. Conversely, the others segment, which includes monoclonal antibodies, anti-amyloid beta drugs, and pipeline drugs, is expected to register the fastest CAGR of 11.9% during the analysis period 2024-2030, fueled by rising regulatory approvals and the launch of disease-modifying therapies targeting Alzheimer's pathology. Alzheimer's Drugs Market Analysis by Route of Administration Oral drugs lead the market with an estimated share of 57% in 2024 due to their ease of administration and non-invasive nature, which enhances patient compliance. Oral medications, such as cholinesterase inhibitors, can be self-administered, providing convenience for patients, especially elderly individuals with multiple comorbidities. The injectable segment is projected to record the fastest growth, with a CAGR of 11.7% during the forecast period from 2024 to 2030, driven by monoclonal antibodies like Aducanumab and Leqembi, which offer potential disease-modifying effects for advanced Alzheimer's stages. Alzheimer's Drugs Market Analysis by Distribution Channel The hospital pharmacy segment dominates the market with an estimated 47.7% share in 2024, driven by increasing procurement of prescription drugs and its role in integrated care models. Hospital pharmacies coordinate multidisciplinary approaches that include pharmaceutical interventions, counseling, and community support, ensuring comprehensive care for Alzheimer's patients. Meanwhile, the online pharmacy segment is anticipated to grow significantly, with a CAGR of 12.7% during the analysis period 2024-2030. This growth is fueled by the rising number of Alzheimer's patients and the convenience of online purchasing, which is particularly beneficial for elderly people, and disabled individuals, supported by increased internet usage and digital service adoption. Alzheimer's Drugs Market Report Scope This global report on Alzheimer's Drugs analyzes the market based on drug class, route of administration and distribution channels. In addition to providing profiles of major companies operating in this space, the latest corporate and industrial developments have been covered to offer a clear panorama of how and where the market is progressing. Key Metrics Historical Period: 2021-2023 Base Year: 2023 Forecast Period: 2024-2030 Units: Value market in US$ Companies Mentioned: 10+ Key Attributes: Report Attribute Details No. of Pages 253 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $5.2 Billion Forecasted Market Value (USD) by 2030 $9.2 Billion Compound Annual Growth Rate 9.9% Regions Covered Global Key Topics Covered: PART A: GLOBAL MARKET PERSPECTIVE 1. INTRODUCTION Product Outline Alzheimer's Drugs Defined Alzheimer's Drug Classes Cholinesterase Inhibitors NMDA Receptor Antagonists Combination Drugs Others (Including Monoclonal Antibodies, Anti-amyloid Beta, Nutritional supplements, and Pipeline Drugs) Alzheimer's Drug Route of Administration Oral Injectable Transdermal Patch Alzheimer's Drug Distribution Channels Hospital Pharmacy Retail Pharmacy Online Pharmacy 2. Key Market Trends 3. Key Global Players AbbVie Inc. AstraZeneca Biogen Inc. Daiichi Sankyo Company Eisai Co. Eli Lilly F. Hoffmann-La Roche H. Lundbeck Johnson & Johnson Innovative Medicine Lupin Merck & Co. Novartis Pfizer Teva Pharmaceutical Industries 4. Key Business & Product Trends 5. Global Market Overview Global Alzheimer's Drugs Market Overview by Drug Class Alzheimer's Drug Class Market Overview by Global Region Cholinesterase Inhibitors NMDA Receptor Antagonists Combination Drugs Others Global Alzheimer's Drugs Market Overview by Route of Administration Alzheimer's Drugs Route of Administration Market Overview by Global Region Oral Injectable Transdermal Patch Global Alzheimer's Drugs Market Overview by Distribution Channel Alzheimer's Drugs Distribution Channel Market Overview by Global Region Hospital Pharmacy Retail Pharmacy Online Pharmacy PART B: REGIONAL MARKET PERSPECTIVE PART C: GUIDE TO THE INDUSTRY PART D: ANNEXURE For more information about this report visit https://www.researchandmarkets.com/r/yrke1t About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

29 Jul 2024

·www.echemi.com

EU Rejects Approval for Alzheimer's Drug Leqembi, Battering Stock of Developer Biogen

Alzheimer's disease, this profound neurodegenerative disease, undoubtedly casts a heavy shadow over the patients and their families. In recent years, the elites of the pharmaceutical industry have spared no effort to devote themselves to the research and development of new treatments in the hope of bringing light to patients. However, a piece of news recently came, but like a dark cloud covering the sun, it is very frustrating. On July 26, 2023, the European Medicines Agency (EMA) officially issued a statement to give negative feedback on the marketing application of Leqembi (Lecanemab), a new drug for Alzheimer's disease jointly developed by Isai and Biogen. After deliberation, EMA's Medicines Review Committee noted that although Leqembi showed slight signs of efficacy in clinical trials, the potential for significant side effects was too strong to ignore. Specifically, the new drug may cause serious complications such as brain swelling and bleeding, and some patients even need to be hospitalized. It is particularly alarming that the patient population carrying the APOE4 gene is at significantly increased risk of these adverse reactions. EMA's decision undoubtedly poured cold water on the market, which had high hopes. After the news, Biogen's share price plummeted, falling more than 7%, which is a sign of the strong market reaction. In the face of this setback, the two pharmaceutical giants of Isai and Biogen quickly said that they will actively cooperate with the EMA and other regulatory agencies to jointly seek the possibility of Leqembi's re-examination of the listing application in the EU region. It is worth noting that despite the setbacks in Europe, Leqembi has been approved by the FDA in the United States. At the same time, two other new Alzheimer's drugs, Aduhelm and Donanemab, are in the process of being approved around the world, and their fate is also affecting the pharmaceutical industry. The future direction of these three new drugs will undoubtedly become the focus of attention in the global medical field. We know that the treatment of Alzheimer's disease is still a long and challenging road. However, we firmly believe that with the continuous efforts of scientists, more safe and effective therapies will emerge in the future, bringing good news to the majority of patients. Let's look forward to that day.

Drug Approval

11 Jul 2024

·www.fiercepharma.com

The end of the beginning: Lilly execs eye top spot in burgeoning Alzheimer's market after Kisunla's FDA approval

Lilly's Alzheimer's disease therapy Kisunla won FDA approval in early July. As the company eyes a market showdown with Eisai and Biogen, Lilly executives recently spoke about their Kisunla launch plans. Following this month's FDA approval of Eli Lilly’s amyloid-busting antibody Kisunla (donanemab), the Alzheimer’s disease market is set to grow in earnest—and Lilly is already eyeing a spot at the top. The green light—which cleared Kisunla to treat adults with early symptomatic Alzheimer’s disease (AD)—marks the culmination of more than 30 years of work in the disease field by Eli Lilly. Those efforts also required concurrent development of non-therapeutic resources like diagnostics to detect amyloid plaque in the brain, Dawn Brooks, global development leader for Alzheimer’s disease at Eli Lilly, said in a recent interview. As with Eisai and Biogen’s AD antibody counterpart Leqembi (lecanemab), Kisunla's FDA-approved label requires the confirmation of amyloid beta pathology in patients’ brain tissue before they begin treatment. On the back of Eisai and biogen’s full approval for Leqembi last year, Kisunla now provides a second option for patients in the early stages of AD. The arrival of a second approved therapy likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, VP of U.S. Alzheimer’s disease marketing at Lilly, added during the interview. Pre-approval preparations Prior to Kisunla’s FDA nod, Lilly was focused on laying the groundwork for the burgeoning Alzheimer’s disease treatment scene, primarily through the development of diagnostics, as well as raising awareness around the fact that “amyloid is the bad guy” affecting patients’ memory and thinking, Lechleiter said. The company has been working to educate healthcare providers and imaging sites on how to use amyloid PET scans and other biomarker tests to diagnose AD, he added. “From a consumer standpoint, we need to drive a sense of urgency,” Lechleiter said. Lilly will aim to accomplish that goal through disease state education and other campaigns with physicians, he explained. As for Kisunla’s inevitable market square-off with Eisai and Biogen’s Leqembi, “a rising tide raises all boats,” Lechleiter said. Still, Lilly’s primary ambition isn’t just to compete, but to build out a modern Alzheimer’s disease treatment landscape and then “lead the market,” Lechleiter said. Despite Leqembi’s full FDA approval last summer, there is still a massive unmet need among early Alzheimer’s patients, he pointed out. “Alzheimer’s is really the competition here, and so building that market is really our first priority,” Lechleiter said. The coverage equation Lilly's drug arrives at somewhat of an opportune time, given that the Centers for Medicare and Medicaid Services (CMS) last summer rolled back its strict national coverage determination for amyloid-targeting Alzheimer’s meds. While the coverage revamp doesn’t mean everything will be smooth sailing from now on out, it does represent “a massive barrier that has been removed,” Lechleiter said. Last summer, CMS blueprinted plans to broadly cover the new class of Alzheimer’s disease drugs that includes Kisunla and Leqembi once the therapies win full approval at the FDA. As part of the framework, the drugmakers behind the Alzheimer’s meds must enroll patients in real-world data collection registries to support the ongoing merit of their products. “Our hope is that the Medciare registry portal includes customers very quickly and we have the intention of that happening and then ensuring that reimbursement is a smooth process for those clinics and institutions that would like to use Kisunla for the appropriate patients,” Lechleiter said. CMS released the latest coverage decision after issuing a narrower coverage framework in 2022 for Leqembi's failed predecessor, Aduhelm. Under that coverage framework, CMS said new Alzheimer's antibodies approved under the FDA’s accelerated pathway would only be covered when administered in eligible clinical trials. Lechleiter did acknowledge potential remaining hurdles to treatment like high out-of-pocket costs for some patients, as well as geographic access to the diagnostics required to qualify for treatment. Stopping treatment and looking to the future Beyond the fact that the drug is infused once a month rather than biweekly like Leqembi, Kisunla could offer a major convenience edge insofar as the antibody can potentially be stopped once patients have brought their amyloid levels down successfully, Brooks explained. Pointing to Lilly’s TRAILBLAZER trial for Kisunla, Brooks noted that certain patients were able to stop treatment as soon as six months after initiating therapy. “We continued to follow those patients in the course of the 18-month study and found that the trajectory of those compared to placebo continued to widen, meaning that you were on a disease-modifying trajectory compared to those that hadn’t received treatment at all,” she explained. At the same time, Lilly is also run a long-term extension study to track Kisunla’s broader effects on patients’ memory and thinking over time. The main takeaway on potential Kisunla stoppage, to hear Brooks tell it, is that amyloid re-accumulation seems to occur “at a very slow rate.” Plaque typically accumulates over 10 to 20 years, but once that block has been cleared or brought down to acceptable levels, “it also re-accumulates at that same very slow rate,” Brooks pointed out. “We would expect that it’s going to be many years before you’re back in a position of it being a positive level,” which shouldn’t be a near-term concern for patients, Brooks said. As for what comes next in the field, Lilly is currently working on its TRAILBLAZER ALZ-3 study, which is looking at whether Kisunla could prevent the onset of symptoms associated with Alzheimer’s disease, Brooks pointed out. The primary measure for that study is expected to read out in October of 2027.

Drug Approval

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Discovery	US	Chimerna Therapeutics, Inc.	28 Feb 2024

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