Kisunla (donanemab-azbt) / Eli Lilly - LARVOL DELTA

Overview of Alzheimer's Disease Neuroimaging Initiative and future clinical trials. (PubMed, Alzheimers Dement) - "Additionally, ADNI provided data for the trials of the FDA-approved treatments aducanumab, lecanemab, and donanemab. It successfully validated amyloid and Tau PET imaging, as well as CSF and plasma biomarkers, for diagnosing Alzheimer's disease. ADNI generated and disseminated vital data for designing AD clinical trials."

Journal • Review • Alzheimer's Disease • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Do Caregivers Value the New Antiamyloid Treatments for Alzheimer's Disease More Than Home-Based Care? (PubMed, Am J Geriatr Psychiatry) - "Our findings show most caregivers perceive modest clinical value in the novel antiamyloid therapies, and the decision to use these drugs will be preference-sensitive, pointing to the need for thorough informed consent discussions."

Journal • Alzheimer's Disease • CNS Disorders

Synthesis and Characterization of Transferrin and Cell-Penetrating Peptide-Functionalized Liposomal Nanoparticles to Deliver Plasmid ApoE2 In Vitro and In Vivo in Mice. (PubMed, Mol Pharm) - "Recently, new treatment approaches involving drugs such as donanemab and lecanemab have been introduced for AD. Notably, treatment with dual-functionalized liposomes resulted in a 2-fold increase in ApoE2 expression levels compared to baseline levels. These findings highlight the potential of dual-functionalized liposomes as an efficacious delivery system for ApoE2 gene therapy in AD, highlighting a promising strategy to address the disease's underlying mechanisms."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Gene Therapies • APOE • CGN

A cross-sectional analysis of open payments from pharmaceutical companies to memory center physicians. (PubMed, J Am Geriatr Soc) - "Most physicians working in a sample of memory clinics received no or low amounts of general payments. Neurologists were more likely to receive general payments from industry. Payments from Biogen, Eisai, and Eli Lilly and Company/Lilly USA were substantial. Future work should evaluate the relationship between industry payments and anti-amyloid prescribing patterns."

Journal • Alzheimer's Disease • CNS Disorders • Psychiatry

Evaluating clinical meaningfulness of anti-β-amyloid therapies amidst amyloid-related imaging abnormalities concern in Alzheimer's disease. (PubMed, Brain Commun) - "Aducanumab, lecanemab and donanemab clinical trials showed slowing of Alzheimer's disease progression on composite scores by 25-40% based on the measure used. Amyloid-related imaging abnormalities typically occur early in treatment and are often asymptomatic, and though in rare cases, they can lead to serious or life-threatening events. The aim of this review is to evaluate the clinical meaningfulness of anti-β-amyloid therapies amidst amyloid-related imaging abnormalities concern in Alzheimer's disease."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia

Lilly's Kisunla (donanemab-azbt) Approved in China for the Treatment of Early Symptomatic Alzheimer's Disease (PRNewswire) - "Eli Lilly and Company...announced that the National Medical Products Administration (NMPA) in China has approved Kisunla (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Eli Lilly and Company's...Alzheimer's treatment for adults with early symptomatic Alzheimer's disease, which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of Alzheimer's disease who have confirmed amyloid pathology....The application to the NMPA was based on the efficacy and safety data from TRAILBLAZER-ALZ 2 Phase 3 clinical study."

China approval • Alzheimer's Disease • Cognitive Disorders • Dementia

Treatment of Alzheimer Disease. (PubMed, Continuum (Minneap Minn)) - "In July 2023, lecanemab became the first of these to gain full US Food and Drug Administration (FDA) approval and limited Medicare payment coverage. Donanemab gained similar approval status in July 2024...Also in 2023, brexpiprazole became the first agent specifically approved by the FDA for agitation associated with AD. Suvorexant, an orexin receptor antagonist, previously was approved for the treatment of insomnia in people with mild and moderate AD...More limited studies support the use of memantine in moderate and severe stages...Pharmacotherapy for behavioral and psychological symptoms is less predictable, and most clinical trials have had negative results. Anti-amyloid therapies provide the first FDA-approved option to alter AD pathology, but an understanding of overall utility and value to patients remains in its infancy."

Journal • Review • Alzheimer's Disease • Cerebral Hemorrhage • CNS Disorders • Dementia • Hematological Disorders • Insomnia • Sleep Disorder

Evaluating Cognitive Decline in Early Alzheimers Disease Using Donanemab (ASHP 2024) - No abstract available

Alzheimer's Disease • CNS Disorders

Donanemab Untangling the Web of Alzheimers Care (ASHP 2024) - No abstract available

Alzheimer's Disease • CNS Disorders

Comparison of New Alzheimers Disease Treatments Donanemab Kisunla and Lecanemab Leqembi Versus Established Therapies (ASHP 2024) - No abstract available

Alzheimer's Disease • CNS Disorders

Disease-modifying therapies for Alzheimer's disease: clinical trial progress and opportunity. (PubMed, Ageing Res Rev) - "The U.S. Food and Drug Administration (FDA) recently approved lecanemab and donanemab for the treatment of early symptomatic Alzheimer's disease (AD) after their phase III trials reached endpoints. In this review, we delineate the core principles and methodologies of diverse DMTs, covering the advances in clinical trials of drug candidates that either have been discontinued, completed, or are ongoing, as well as brain stimulation and lifestyle interventions. In addition, by overseeing the fate of various candidate molecules, we hope to provide references and ideas for prospective approaches and promising applications of DTMs for AD, particularly in terms of universality and clinical application economics, to optimize efficacy and maximize AD patient benefits in the future."

Journal • Review • Alzheimer's Disease • CNS Disorders

Evaluating Donanemab: Advances and Challenges in Alzheimer Disease Treatment. (PubMed, Am J Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Comparison of the efficacy of updated drugs for the treatment on the improvement of cognitive function in patients with Alzheimer 's disease: A systematic review and network meta- analysis. (PubMed, Neuroscience) - "Donanemab and Lecanemab showed good efficacy in ADCS-ADL and CDR-SB, respectively. GV-971 is the best choice to improve ADAS cogs and NPI."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Disease Modifying Monoclonal Antibodies and Symptomatic Pharmacological Treatment for Alzheimer's Disease. (PubMed, Biomedicines) - "Three monoclonal antibodies that act against amyloid beta-aducanumab, lecanemab, and donanemab-have been approved by the Food and Drug Administration (FDA) for the treatment of mild cognitive impairment and mild AD, in addition to medications for cognitive symptom management such as acetylcholinesterase inhibitors and the N-methyl-D-aspartate (NMDA) antagonist. Further trials should focus on the combination of therapies targeting amyloid plaques and tau pathology."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Revolutionizing Alzheimer's Diagnosis and Management: The Dawn of Biomarker-Based Precision Medicine. (PubMed, Dement Neurocogn Disord) - "The treatment landscape is shifting toward personalized medicine, highlighted by advancements in Aβ immunotherapies, such as lecanemab and donanemab. The integration of fluid biomarkers into clinical practice represents a significant advance in AD management, providing the potential for early and precise diagnosis, coupled with personalized therapeutic approaches. This heralds a new era in combating this debilitating disease."

Biomarker • IO biomarker • Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • NEFL

A Transcriptomics-Based Machine Learning Model Discriminating Mild Cognitive Impairment and the Prediction of Conversion to Alzheimer's Disease. (PubMed, Cells) - "Although a few disease-modifying treatments, such as lecanemab and donanemab, have been developed, current therapies can only delay disease progression rather than halt it entirely. This integrated approach could facilitate the development of novel diagnostic tools and therapeutic strategies aimed at delaying or preventing the onset of AD in at-risk individuals. Future studies should focus on validating these biomarkers in larger, independent cohorts and further investigating their roles in AD pathogenesis."

Biomarker • Journal • Machine learning • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • NEFL • p-tau181

Passive anti-amyloid β immunotherapy in Alzheimer's disease-opportunities and challenges. (PubMed, Lancet) - "We discuss clinical trial results of aducanumab, lecanemab, and donanemab. In our view, we are experiencing a fundamental shift from syndrome-based Alzheimer's dementia care to early, biomarker-guided treatment of Alzheimer's disease. This shift requires substantial adjustments of infrastructure and resources, but also holds promise of eventually achieving substantial slowing of disease progression and delaying dementia."

IO biomarker • Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia

Use of anti-amyloid therapies for Alzheimer's disease in Brazil: a position paper from the Scientific Department of Cognitive Neurology and Aging of the Brazilian Academy of Neurology. (PubMed, Dement Neuropsychol) - "Novel therapies for Alzheimer's disease, particularly anti-amyloid drugs like lecanemab and donanemab, have shown modest clinical benefits but also significant risks. Recommendations include careful patient selection, risk-benefit analysis, and the importance of proven amyloid pathology for treatment. Future work involves further research on anti-amyloid therapies in Brazil and the development of more effective treatments for Alzheimer's disease."

Journal • Alzheimer's Disease • CNS Disorders

Critical assessment of anti-amyloid-β monoclonal antibodies effects in Alzheimer's disease: a systematic review and meta-analysis highlighting target engagement and clinical meaningfulness. (PubMed, Sci Rep) - "In subgroup analyses by individual drug, Donanemab and Lecanemab induced the largest benefits. PROSPERO registration no. CRD42022381334."

Clinical • Journal • Retrospective data • Review • Alzheimer's Disease • CNS Disorders

Lilly’s Kisunla does not demonstrate ’good value’ for UK’s NHS (Yahoo Finance) - "Eli Lilly’s Kisunla (donanemab) will not yet be made available to Alzheimer’s patients in the UK after the National Institute for Health and Care Excellence (NICE) said it doesn’t demonstrate good value for UK's NHS...NICE, which acts as the UK’s price watchdog, said that although the monthly injection slows disease progression by four to seven months, as demonstrated in the Phase III TRAILBLAZER-ALZ 2 (NCT04437511) study, there are 'significant uncertainties about how much benefit donanemab provides, and how long this lasts for after stopping treatment'. It also said that more evidence is needed on the clinical and cost-effectiveness of Kisunla."

NICE • Alzheimer's Disease • CNS Disorders

ABTrans: A Transformer-based Model for Predicting Interaction between Anti-Aβ Antibodies and Peptides. (PubMed, Interdiscip Sci) - "Using ABTrans, we examined the cross-reaction of anti-Aβ antibodies with other human amyloidogenic proteins, revealing that Aducanumab and Donanemab exhibited the least cross-reactivity. Additionally, we systematically screened interactions between eleven selected anti-Aβ antibodies and all human proteins to identify potential off-target candidates."

Journal • Alzheimer's Disease • CNS Disorders

Differential Health-Economic Outcomes of Anti-Amyloid Treatment for Alzheimer's Disease Between Ethnoracial Groups in the United States (ISPOR-EU 2024) - " We used a previously validated mathematical model of Alzheimer’s disease treatment to project health and economic outcomes under usual care vs. with donanemab (an exemplar anti-amyloid antibody) for three ethnoracial groups: Hispanic, non-Hispanic Black, and non-Hispanic White... Based on current ethnoracial disparities in AD care, the benefits and costs of anti-amyloid treatment are likely to be unevenly distributed between ethnoracial groups, with Black individuals receiving a markedly lower share of the benefits. Efforts to improve timely diagnosis rates for Black patients would facilitate a more equitable distribution of benefits."

HEOR • Alzheimer's Disease • CNS Disorders

Modified Titration of Donanemab Demonstrated Reduction of ARIA-E in Early Symptomatic Alzheimer's Disease Patients in Phase 3b study (PRNewswire) - P3b | N=800 | TRAILBLAZER-ALZ 6 (NCT05738486) | Sponsor: Eli Lilly and Company | "Eli Lilly and Company...today announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease (AD)....The only difference between the modified titration and the standard dosing regimen is the shift of one vial from the first infusion to the third infusion. Pharmacokinetic (PK) analysis demonstrated equivalent cumulative exposure between modified titration and standard dosing regimen."

P3 data • Alzheimer's Disease • CNS Disorders

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease (clinicaltrials.gov) - P=N/A | N=3060 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • Real-world • Real-world evidence • Alzheimer's Disease • CNS Disorders

Chemical-Driven Amyloid Clearance for Therapeutics and Diagnostics of Alzheimer's Disease. (PubMed, Acc Chem Res) - "However, recent approvals of anti-Aβ antibody drugs by the FDA, including aducanumab (Aduhelm), lecanemab (Leqembi), and donanemab (Kisunla), have prompted a re-evaluation of this perspective. In clinical practice, we anticipate that these findings will contribute to the development of patient-friendly therapeutic and diagnostic interventions, including self-administered and orally available options, thereby enhancing disease management and overall quality of life for individuals with AD. Furthermore, this research extends beyond AD, potentially offering insights into other neurodegenerative diseases characterized by protein aggregation."

IO biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders