Lecanemab

Stanley Druckenmiller's Duquesne Family Office exited Eli Lilly, but the stock's potential remains high due to its Alzheimer's drug, eczema treatment, and AI initiatives.

Leqembi, an Alzheimer’s drug, reduces beta-amyloid plaques but doesn't halt cognitive decline; it may speed dementia by causing brain shrinkage. Eisai, the maker, kept genetic test results secret, violating informed consent. Despite modest trial results, FDA approved Leqembi in 2023; EU and Australia declined approval due to side effects. FDA has a history of bias towards drug approval, criticized for approving Aduhelm in 2021 against advisory committee's advice.

MHRA approved Eli Lilly’s Kisunla for mild Alzheimer’s disease, but NICE initially declined NHS coverage due to cost-effectiveness and risk-benefit concerns. This follows a similar NICE decision for Eisai/Biogen’s Leqembi in August 2024. Both drugs showed modest cognitive decline reduction in trials, with Kisunla having a higher rate of ARIA-E side effects. NICE’s decisions are not final and await further evidence, with long-term effects and real-world data crucial for their success.

NICE not recommending Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla (donanemab) for NHS use despite MHRA approval for mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD). This follows a similar NICE decision on Eisai/Biogen’s Leqembi (lecanemab) in 2024, due to cost-effectiveness and safety concerns. Both drugs, though representing a breakthrough, have modest efficacy and pose risks like amyloid-related imaging abnormalities (ARIAs). NICE decisions are not final, awaiting further evidence on drug effects and costs. GlobalData forecasts $3.5 billion and $2.0 billion sales for Leqembi and Kisunla, respectively, in the 8MM by 2030.

Eisai and Eli Lilly withheld genetic risk info from Alzheimer's drug trial volunteers, leading to brain injuries and deaths. FDA approved Leqembi in 2023 despite risks, raising concerns about patient safety and Alzheimer's research approach.

Eli Lilly’s Kisunla (donanemab) won’t be available to UK Alzheimer’s patients due to NICE’s assessment of poor value for NHS. MHRA approved it for mild cognitive impairment or dementia, but NICE cites uncertainties in benefits and safety concerns like brain swelling or bleeding. Cost-effectiveness estimates are 5-6 times higher than NICE’s acceptable threshold.

The UK approved Alzheimer’s drug Kisunla but won’t fund it due to cost concerns. This follows a similar decision on Leqembi in August. Kisunla, known as donanemab, removes a sticky protein from the brain, but the National Institute for Health and Care Excellence (NICE) requires more evidence of its value. A year’s treatment costs $32,000, and NICE cites high administration costs and potential side effects. Despite the setback, experts remain hopeful for future Alzheimer’s treatments.

Eli Lilly’s amyloid plaque-targeting Alzheimer’s drug, Kisunla, approved by MHRA but not recommended by NICE for NHS use due to cost concerns. NICE cites 'significant uncertainties' and 'relatively small' benefit, with a final decision expected in 2025.

The UK launches the Dementia Trials Accelerator (DTA) with £20 million funding to increase dementia trial participation from 61 to tens of thousands. Led by UK DRI and HDR UK, DTA aims to make the UK the top destination for pharma and industry to run late-phase clinical trials, leveraging world-class science and data infrastructure. The initiative addresses obstacles to commercial trials, including streamlined processes, and aims to offer patients access to potentially life-changing treatments through increased trial opportunities.