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
- -
FDA gave its nod to 55 new drugs in 2023
In 2023, the FDA approved 55 new molecular entities, a significant increase from 37 in 2022, with 56% being small-molecule therapies. Notable approvals included Eisai and Biogen’s Leqembi for Alzheimer’s, and the first CRISPR-based treatment, Casgevy, for sickle cell disease.
The European Medicines Agency's Scientific Advisory Group to Discuss Lecanemab's Marketing Authorisation Application in the EU
Eisai announced the Scientific Advisory Group (SAG) will discuss lecanemab's Marketing Authorisation Application (MAA) in the EU, with a decision expected in Q2 2024. Lecanemab, developed with BioArctic, is a treatment for Alzheimer's, approved in the US, Japan, and China. BioArctic plans to commercialize lecanemab in the Nordic region with Eisai.
Biotech Stock Roundup: BIIB, Eisai's Drug Update, NVAX Gains on Deal Amendment
Biogen and Eisai's Alzheimer's drug Leqembi received full FDA approval, enabling broader Medicare coverage. Novavax's stock surged after amending its vaccine deal with Canada, involving a $349.6M payment. Caribou Biosciences gained from Pfizer's $25M investment, advancing its CAR-T cell therapy. Prothena secured a $55M deal with Bristol Myers Squibb for Alzheimer's treatment rights.
Biogen Inc. (BIIB) Down 0.2% Since Last Earnings Report: Can It Rebound?
Biogen Inc. reported Q2 2023 earnings of $4.02 per share, beating estimates, despite a 23% year-over-year decline. Sales fell 5% to $2.46 billion, impacted by lower MS drug sales. MS revenues dropped 15%, with Tecfidera sales down 36%. Spinraza sales rose 1% to $437 million. Biogen expects MS revenues to decline in 2023 due to competition. The company is focusing on cost-saving initiatives and restructuring, aiming for $1 billion in savings by 2025.
Eisai Plans to Submit BLA for Subcutaneous Lecanemab
At CTAD 2023, Eisai presented data showing subcutaneous lecanemab removes amyloid plaques 14% more effectively than IV, with plans to submit a biologics license application by March 31, 2024. Subcutaneous administration also showed higher pharmacokinetic AUC and similar ARIA-E rates, indicating potential for disease modification.
US announces trial Medicare payment program for care providers of dementia patients
The U.S. government announced a trial payment program for dementia care coordination under Medicare, aiming to delay nursing home care. It includes personalized assessments, care plans, and 24/7 support. The pilot will test a per-patient per-month payment model, starting July 2024 for eight years, targeting 6.5 million Americans with dementia.
US announces 8-year-trial Medicare payment program for caretakers of dementia patients
The U.S. government announced a trial payment program for dementia care coordination under Medicare, offering personalized assessments, care plans, and 24/7 support. Aimed at delaying nursing home care, it includes a per-patient per-month payment model and access to clinical and non-clinical services. Applications open autumn 2023, with the trial running from July 2024 for eight years.
Second Alzheimer’s drug to slow disease’s progression may be approved in the US this year
Leqembi, the first FDA-approved Alzheimer's drug proven to slow disease progression, may soon be joined by Eli Lilly's donanemab. Both target amyloid protein in the brain, showing modest benefits in slowing cognitive decline. Despite safety concerns and high costs, they offer hope for early-stage Alzheimer's patients.
Leqembi: First Alzheimer’s drug to slow disease progression gets full FDA approval, triggering broader Medicare coverage
The FDA fully approved Leqembi, the first Alzheimer's drug proven to slow disease progression, expanding Medicare coverage to potentially benefit a million early-stage patients. Despite its $26,500 annual cost and side effects requiring monitoring, it offers hope for more time with loved ones, though not a cure.
What to Know About Leqembi, the Alzheimer’s Drug Approved by the FDA
FDA approved Leqembi for early Alzheimer's, with Medicare covering 80% of its $26,500 annual cost. It modestly slows cognitive decline but doesn't cure or stop disease progression. Risks include brain swelling or bleeding, with a required black-box warning for serious side effects.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
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