Lecanemab
- Generic Name
- Lecanemab
- Brand Names
- Leqembi
- Drug Type
- Biotech
- CAS Number
- 1260393-98-3
- Unique Ingredient Identifier
- 12PYH0FTU9
- Background
Lecanemab is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ), which are implicated in the pathophysiology of Alzheimer’s disease. Lecanemab works to reduce Aβ plaques and prevent Aβ deposition in the brain with high selectivity to Aβ protofibrils. In clinical trials, it significantly reduced brain Aβ plaques compared to placebo.
On January 6, 2023, lecanemab was granted accelerated approval by the FDA for the treatment of Alzheimer’s Disease. It was granted full FDA approval on July 6, 2023.
- Indication
Lecanemab is indicated for the treatment of Alzheimer’s disease. Treatment with lecanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
- Associated Conditions
- Alzheimer's Disease (AD)
Sanofi to Acquire Vigil Neuroscience for Up to $600 Million, Expanding Alzheimer's Disease Pipeline
• Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for $8.00 per share in cash upfront, with an additional $2.00 per share contingent value right tied to VG-3927's first commercial sale.
• The acquisition strengthens Sanofi's neurology pipeline with VG-3927, a Phase 2-ready oral small molecule TREM2 agonist being developed for Alzheimer's disease, targeting microglial dysfunction in neurodegenerative disorders.
• The transaction, valued at approximately $600 million including the potential CVR payment, is expected to close in the third quarter of 2025, with Vigil's monoclonal antibody program iluzanebart not included in the acquisition.
FDA Approves Novavax COVID-19 Vaccine with Restricted Use for High-Risk Groups
• The FDA has granted full approval for Novavax's protein-based COVID-19 vaccine, but with unusual restrictions limiting its use to adults 65 and older or those 12-64 with health risk factors.
• Novavax's vaccine represents the only traditional protein-based coronavirus vaccine option in the US market, previously available under emergency authorization for anyone 12 and older.
• The restricted approval comes amid shifting vaccine policies under the Trump administration, with the FDA requiring Novavax to conduct additional post-approval studies on potential heart conditions and benefits for certain age groups.
Algernon Pharmaceuticals Enters Alzheimer's Diagnostic Market with NoBrainer Imaging Centers Acquisition
• Algernon Pharmaceuticals has entered into agreements to acquire NoBrainer Imaging Centers, gaining exclusive rights to establish Alzheimer's diagnostic and treatment clinics across Canada and select U.S. markets.
• The company plans to open comprehensive Alzheimer's clinics featuring the FDA-cleared Positrigo NeuroLF brain PET scanner, offering services from genetic screening to administration of FDA-approved therapies like Kisunla and Leqembi.
• With an estimated 7 million Americans and 750,000 Canadians living with Alzheimer's, the market for PET scans at approximately $5,000 per scan is projected to exceed $18 billion, addressing a critical shortage in brain-specific imaging capabilities.
FDA-Approved Alzheimer's Drug Lecanemab Shows Manageable Safety Profile in Real-World Setting
• WashU Medicine researchers found only 1% of Alzheimer's patients treated with lecanemab experienced severe side effects requiring hospitalization, confirming clinical trial safety data in a real-world setting.
• Patients with very mild Alzheimer's symptoms showed significantly lower risk (1.8%) of adverse events compared to those with mild symptoms (27%), suggesting earlier treatment may optimize both efficacy and safety.
• The study of 234 patients demonstrates that specialized memory clinics can effectively manage ARIA (amyloid-related imaging abnormalities), with most cases being asymptomatic and resolving without intervention.
Biogen Advances LEQEMBI Treatment with Subcutaneous Formulation for Alzheimer's Disease
• Biogen is developing a subcutaneous formulation of LEQEMBI for maintenance therapy, which could simplify treatment for Alzheimer's patients after 18 months of biweekly infusions.
• The subcutaneous administration option may increase patient adherence, reduce burden on infusion centers, and provide better accessibility for patients in rural settings.
• Fujirebio's in-vitro diagnostic tool is expected to facilitate earlier diagnosis of Alzheimer's disease, allowing treatment before significant neuronal damage occurs.
Promising Alzheimer's Vaccine Targeting Tau Protein Advances Toward Human Trials
• University of New Mexico researchers have developed a vaccine that generates antibodies against pathological tau protein (pT181), showing efficacy in both mice and non-human primates with strong immune responses.
• The vaccine uses virus-like particles (VLPs) as a delivery platform, requiring only one primary shot and two boosters without adjuvants, demonstrating safety and durability in preclinical studies.
• Researchers are now seeking funding to advance to Phase 1 human clinical trials, potentially offering a more effective approach than current amyloid beta-targeting treatments that show only modest effects on Alzheimer's progression.
Precision Medicine in Alzheimer's Disease: Mayo Clinic Expert Outlines Future of Targeted Treatments
• Current Alzheimer's treatments follow a one-size-fits-all approach despite the disease's complex biology, failing to address diverse molecular pathways driving progression in individual patients.
• Precision medicine aims to classify patients by disease subtype and stage, tailoring therapies to maximize benefits and minimize risks based on biological markers, similar to modern cancer treatment approaches.
• Multidisciplinary collaboration, particularly involving pharmacists, will be essential as treatment strategies evolve toward multimodal therapies that must adapt throughout the chronic progression of neurodegenerative diseases.
FDA Delays Approval of Eli Lilly's Alzheimer's Drug Donanemab, Requests Additional Safety Data
• The FDA has issued a complete response letter for Eli Lilly's Alzheimer's drug donanemab, requesting data from at least 100 patients with 12 months of continued treatment before considering accelerated approval.
• Donanemab's unique trial design, which allowed patients to discontinue treatment after amyloid plaque clearance, has complicated the safety assessment process, prompting the FDA to schedule an advisory committee meeting.
• If eventually approved, donanemab would become only the second disease-modifying Alzheimer's treatment on the market after Eisai/Biogen's Leqembi, with clinical trials showing it can slow cognitive decline by 4-7 months.
Roche Launches SKYLINE: Four-Year Prevention Trial for Gantenerumab in Early-Stage Alzheimer's
• Roche initiates SKYLINE study, enrolling 1,250 participants aged 60-80 with early biological markers of Alzheimer's but no cognitive impairment, to evaluate gantenerumab's effectiveness in disease prevention.
• The study represents a significant investment in Alzheimer's research, featuring collaboration with prestigious institutions including Banner Alzheimer's Institute and Massachusetts General Hospital.
• Gantenerumab offers a potential advantage with its subcutaneous home administration option, distinguishing it from competitors requiring clinical infusions.
Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression
• Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene.
• Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges.
• Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations.
• Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.
FDA Approves Monthly IV Maintenance Dosing for Leqembi, Eases Treatment Burden for Alzheimer's Patients
• The FDA has approved a monthly intravenous (IV) maintenance dose for Leqembi, offering a more convenient treatment schedule for early Alzheimer's disease.
• Patients completing the initial 18-month biweekly IV treatment can transition to monthly dosing, potentially improving long-term adherence and quality of life.
• Approval is based on data modeling showing sustained clinical and biomarker benefits with monthly dosing, addressing the continuous neurotoxic processes of Alzheimer's.
• Leqembi, developed by Eisai and Biogen, is now approved in multiple countries, offering a significant advancement in managing early Alzheimer's disease.
Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests
• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis.
• Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology.
• Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access.
• These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.
Leqembi's EU Approval Faces Further Delay as EMA Re-evaluates Safety Data
• The European Commission has requested the EMA to re-examine Leqembi's safety data, potentially delaying its EU approval beyond the expected timeframe.
• The CHMP will assess recent safety data to determine if an update to its positive opinion is needed, particularly regarding risk minimization measures.
• Eisai and Biogen believe existing data support Leqembi's safety profile, reinforced by clinical use in the US and other approved regions.
• Leqembi is already approved in the US, Japan, China and other countries, with a new once-monthly intravenous maintenance dose approved in the US.
Roche and Lilly's Alzheimer's Blood Test Receives FDA Breakthrough Device Designation
• Roche and Lilly's Elecsys Amyloid Plasma Panel, a blood test for Alzheimer's, has been granted Breakthrough Device Designation by the FDA, expediting its development and review.
• The test detects phosphorylated tau proteins (pTau-217) in the blood, offering a less invasive alternative to PET scans and CSF analysis for early Alzheimer's diagnosis.
• The Elecsys test could help identify patients suitable for new amyloid-targeting drugs and accelerate recruitment into clinical trials, addressing the critical need for early diagnosis.
• With 75% of dementia cases undiagnosed globally, the pTau217 test promises to improve diagnostic rates and potentially alleviate strain on healthcare systems.
Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease
• Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment.
• The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients.
• Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden.
• Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.
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