Science Journals: In Other Journals
- The Food and Drug Administration (FDA) has granted full traditional approval to Leqembi (lecanemab), an Alzheimer's disease drug developed by Eisai and Biogen.
- Leqembi is an antibody-based therapy designed to target and remove amyloid plaques, a hallmark of Alzheimer's disease, from the brain.
- The FDA approval is specifically for patients with early-stage Alzheimer's disease - those with mild cognitive impairment or mild dementia - who have confirmed presence of amyloid plaques...
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Alzheimer’s Drug Leqembi Receives Full FDA Approval, Expanding Access to Treatment
What Happened?
The Food and Drug Administration (FDA) has granted full traditional approval to Leqembi (lecanemab), an Alzheimer’s disease drug developed by Eisai and Biogen. This decision,announced on July 6,2023,marks a critically important shift from the previous conditional approval granted in January 2023,and dramatically expands access to the medication for eligible patients. Previously, leqembi was available under an accelerated approval pathway, limiting it’s use to those participating in clinical trials.
What is Leqembi and How Does it Work?
Leqembi is an antibody-based therapy designed to target and remove amyloid plaques, a hallmark of Alzheimer’s disease, from the brain. These plaques are believed to contribute to the cognitive decline associated with the condition. The drug is administered intravenously every two weeks. It doesn’t cure Alzheimer’s, but aims to slow the progression of cognitive impairment in the early stages of the disease.
Who is Eligible for Leqembi?
The FDA approval is specifically for patients with early-stage Alzheimer’s disease – those with mild cognitive impairment or mild dementia – who have confirmed presence of amyloid plaques in their brains. Confirmation requires a PET scan or cerebrospinal fluid analysis. Patients must also be under the care of a physician experienced in diagnosing and managing Alzheimer’s disease. It’s crucial to note that Leqembi is not suitable for individuals in later stages of the disease.
Clinical Trial Results: What the Data Shows
The approval is based on data from the Phase 3 Clarity AD clinical trial, a large-scale study involving nearly 1,800 participants. Results published in the New England Journal of Medicine demonstrated that Leqembi slowed cognitive decline by 27% over 18 months compared to a placebo. While statistically significant, experts emphasize this is a modest effect. The trial also revealed potential side effects, detailed below.
| Outcome Measure | Leqembi Group | Placebo Group |
|---|---|---|
| Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | 0.44 | 0.65 |
| Percentage of Patients with Amyloid Reduction | 55.3% | 12.3% |
Potential Risks and Side Effects
Leqembi is not without risks. The most serious side effects observed in clinical trials include amyloid-related imaging abnormalities (ARIA), which can manifest as brain swelling (ARIA-E) or microbleeds (ARIA-H). ARIA-E can be asymptomatic or cause symptoms like headache, confusion, or vision changes.ARIA-H typically doesn’t cause symptoms, but its long-term effects are still being studied. Regular MRI monitoring is required to detect and manage ARIA. Other common side effects include infusion-related reactions like fever and chills.
Medicare coverage and Cost
A major hurdle to access has been Medicare coverage.