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
- -
UK MHRA To Retain Multiple Approval Pathways From 2025 - Pink Sheet
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Alzheimer's Drug Discovery Foundation Invests in First-of-its-Kind Biomarker Observatory
The Alzheimer's Drug Discovery Foundation (ADDF) announced a new investment to develop a Biomarker Observatory, led by Dr. Jeffrey Cummings and Co-Principal Investigator Feixiong Cheng, to provide a comprehensive overview of Alzheimer's biomarkers, accelerating drug development. The Observatory will complement Cummings' annual clinical trial report and serve as a key resource for researchers, bridging gaps in Alzheimer's research and advancing precision medicine.
Alzheimer's heterogeneity necessitates diverse enrollment in clinical trials
Clinical trials for Alzheimer's drugs, like Eli Lilly's Kisunla and Eisai's Leqembi, often lack diversity, excluding racial minorities, ApoE4 homozygotes, and patients with comorbidities. This underrepresentation hampers the validation of eligibility criteria in diverse populations, necessitating new cutoffs. Challenges include socioeconomic barriers and inadequate outreach, impacting trial enrollment and patient care.
Related Clinical Trials:
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Alzheimer's Drugs May Work in Whole New Way, Study Finds
Alzheimer's drugs Leqembi and Kisunla may work by boosting levels of healthy amyloid beta (Aβ42) protein, countering Alzheimer's progression, according to a University of Cincinnati study.
Late-Stage Alzheimer's Pipeline Goes Beyond Amyloid and Tau
Eisai and Biogen's Leqembi and Eli Lilly's Kisunla are first anti-amyloid antibodies to slow Alzheimer's cognitive decline. 32 therapeutics in Phase III trials target neuroprotection, neurotransmitters, neurogenesis, inflammation, and proteinopathies. Leqembi and Kisunla have limited efficacy and notable side effects, prompting diverse opinions on clinical benefit. Next-gen therapeutics aim for easier administration and multiple pathways to treat Alzheimer's.
Related Clinical Trials:
Alzheimer's drug Leqembi promises to give patients more time, but they face a long road to treatment
Leqembi, an Alzheimer's drug from Biogen and Eisai, offers early-stage patients more independent living time but faces hurdles like reimbursement issues, diagnostic tests, and neurologist availability. Missie Meeks, an early recipient, reports improved daily functioning. Despite risks like brain swelling and bleeding, some patients find the process worth it for extended normal life.
Leqembi could give Alzheimer's patients more time, but road to treatment is long
Leqembi, an Alzheimer's drug from Biogen and Eisai, promises to extend patients' normal, independent lives, though it's not a cure. Missie Meeks, diagnosed with early Alzheimer's, benefits from Leqembi, which moderately slows cognitive decline. However, the drug's rollout faces challenges like insurance hurdles and limited neurologist availability. Despite risks of brain swelling and bleeding, some patients find the process worth it for extended quality time with loved ones.
Cell and Gene Therapy Shows Early Promise Against Alzheimer’s Disease
Alzheimer’s disease, affecting nearly 7 million in the U.S., sees high clinical trial failure rates. Longeveron and Lexeo Therapeutics lead with novel cell and gene therapies. Longeveron’s Lomecel-B, showing promise in Phase IIa trials, targets broader Alzheimer’s symptoms, while Lexeo’s gene therapies focus on APOE4-associated Alzheimer’s. Both aim to overcome traditional treatment limitations, offering hope for new, effective therapies.
Eli Lilly's Alzheimer's Drug Obtains FDA Approval. Here's Why the Stock Isn't Taking Off
Eli Lilly's Alzheimer's drug, Kisunla, received FDA approval, expected to generate billions. However, the stock didn't surge as the approval was already priced in. The company's focus and investor excitement are more on its GLP-1 treatments for obesity and diabetes, indicating future growth potential beyond Kisunla.
Drug Development Updates
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