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
- -
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The FDA approved donanemab, a monoclonal antibody by Eli Lilly, to slow early Alzheimer's progression. Priced at $695 per vial, it targets amyloid plaque. Clinical trials showed a 35% lower disease progression risk over 18 months compared to placebo, with rare serious side effects. It's not a cure but extends independence. Lilly emphasizes early detection's importance, as Alzheimer's affects millions, with projections to nearly 14 million by 2060. The Alzheimer’s Association welcomes this as progress, offering more treatment options.
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FDA approved donanemab, an Eli Lilly drug, to delay Alzheimer's onset, following lecanemab's approval. It slows cognitive decline by 35% and disease progression risk by 39%, targeting amyloid plaques. Priced at $32,000/year, it's covered by Medicare with risks of brain swelling or bleeding.
FDA advisers endorse Eli Lilly’s early-stage Alzheimer’s drug donanemab
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FDA advisers strongly back new Alzheimer’s drug, despite risks and limitations
FDA advisers unanimously recommend approving Alzheimer’s drug donanemab, highlighting its effectiveness in early stages and benefits outweighing risks. It could allow halting treatment if amyloid plaques are removed, potentially within a year. Concerns include brain swelling/bleeding risks, especially for APOE4 gene carriers, but advocates stress the need for aggressive treatment options.
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CMS estimates Medicare could spend $3.5 billion on Alzheimer's drug Leqembi by 2025, despite current low sales and safety concerns. Similar to Aduhelm's failure, Leqembi's uptake is slow, with modest cognitive benefits and safety risks. Medicare's projections may be overly optimistic, given the drug's limited market penetration and ongoing safety and efficacy concerns.
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Drug Development Updates
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