Lecanemab
- Generic Name
- Lecanemab
- Brand Names
- Leqembi
- Drug Type
- Biotech
- Chemical Formula
- -
- 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)
- Associated Therapies
- -
How decentralisation can fill the gaps in Alzheimer’s research
New Alzheimer's therapies like Kisunla and Leqembi offer hope but face regulatory and access challenges. Decentralised trials have declined, with only 7.09% of Alzheimer's trials being decentralised in 2023. Balancing data collection with patient convenience is crucial, with digital health technologies playing a key role in improving trial accessibility and data quality.
A Year Later, 5 Things We've Learned From Patients on Leqembi
Since Leqembi's approval in 2023, neurologists have learned: 1) it takes 5 months on average to start treatment; 2) Black and Hispanic Americans are underrepresented; 3) most U.S. infusions occur in urban centers; 4) Japan treats more patients with fewer ARIA cases; 5) blood tests aren't yet adequate for confirming Alzheimer's biomarkers.
CareMed Tapped for Breakthrough Alzheimer's Drug Leqembi Distribution
BrightSpring Health Services announces CareMed selected as national specialty pharmacy partner for Leqembi®, an FDA-approved Alzheimer's treatment showing efficacy in slowing cognitive decline over 18 months in Phase III trials.
Cassava's Alzheimer's drug nears P3 readout, but SEC scandal casts long shadow
Cassava Sciences is advancing simufilam through a phase 3 trial, despite SEC controversy over past data integrity. The company aims to release trial results soon, with new leadership emphasizing transparency and ethical practices. The success of simufilam, Cassava's only asset, hinges on these results, which will face heightened scrutiny due to previous data issues.
Alzheimer's Drug Shows Slower Cognitive Decline in Lower Tau Patients
Cognition Therapeutics presented data from its Phase II SHINE trial showing CT1812 significantly slowed cognitive decline in mild-to-moderate Alzheimer’s patients with low baseline plasma p-tau217 levels, with 95% slowing measured by ADAS-Cog 11 and 108% by MMSE. The company plans to discuss Phase III with the FDA in 2025, considering subgroup recruitment strategies and dosing, while facing funding challenges.
Related Clinical Trials:
Korean Dementia Association: “Leqembi's Side Effects Are Not Significant”
The Korean Dementia Association reassures on Leqembi's safety, noting rare side effects like brain hemorrhage. Phase 3 trial results show Leqembi delayed Alzheimer’s progression by 27%, leading to MFDS approval in Korea. Despite EU and Australia's refusal to approve due to ARIA concerns, Korean data reveals fewer side effects in Asians, with only 6.5% incidence of cerebral edema among Korean participants.
7 Alzheimer's and Parkinson's Programs Discarded in 2024
Despite approvals for Leqembi and Kisunla, attrition in Alzheimer’s and Parkinson’s pipelines persists, with Roche, Johnson & Johnson, Sage Therapeutics, and Otsuka discontinuing programs. Analysts attribute these decisions to clinical trial data and evolving commercial opportunities, noting the Alzheimer’s market is projected to be worth $15.5 billion by 2031, while Parkinson’s drugs are expected to reach $6.63 billion by 2029.
UK's NICE Says Alzheimer's Disease Drug Kisunla Is Not Cost-Effective
Kisunla (donanemab) approved by U.S. and U.K. for Alzheimer's, but U.K.'s NICE deems it not cost-effective. Kisunla clears beta amyloid and tau plaque, slowing cognitive decline in trials, but faces reimbursement challenges due to high cost and safety concerns.
New Alzheimer's resource center opening in Oak Cliff
Gail Youngdale, diagnosed with Alzheimer's, participates in a clinical trial for Leqembi, a drug that slows disease progression. Dr. Diana Kerwin, a renowned Alzheimer's researcher, expands her clinic to Oak Cliff, emphasizing accessibility. Leqembi, though not a cure, offers hope by potentially preventing the disease from reaching advanced stages. The Dallas Walk to End Alzheimer's is scheduled for Saturday morning.
Eisai Formally Submits BLA for Subcutaneous Autoinjector of Lecanemab
Eisai submitted a BLA for lecanemab-irmb (Leqembi) subcutaneous autoinjector, aiming for weekly maintenance dosing. If approved, it would offer a 15-second administration method for patients with mild cognitive impairment or early-stage Alzheimer disease. The therapy is currently approved in several countries and under review in others, including the EU. The BLA is supported by phase 3 Clarity AD trial data, showing subcutaneous lecanemab produced greater amyloid plaque removal than IV administration.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath