Science Journals: In Other Journals
- The Food and Drug Management (FDA) has granted full conventional approval to Leqembi (lecanemab), an Alzheimer's disease drug developed by Eisai and Biogen.
- Leqembi is an antibody therapy designed to target and remove amyloid plaques,abnormal protein deposits that accumulate in the brains of people with Alzheimer's disease.
- The full approval was based on data from the Phase 3 clarity AD clinical trial, involving nearly 1,800 participants with early-stage Alzheimer's disease.
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alzheimer’s Drug Leqembi Receives Full FDA Approval, Expanding Access to Treatment
What Happened?
The Food and Drug Management (FDA) has granted full conventional 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 its use to those participating in clinical trials.
How Leqembi Works: Targeting Amyloid Plaques
Leqembi is an antibody therapy designed to target and remove amyloid plaques,abnormal protein deposits that accumulate in the brains of people with Alzheimer’s disease. These plaques are considered a hallmark of the disease, and Leqembi aims to slow the progression of cognitive decline by reducing their burden. The drug is administered intravenously every two weeks.
Clinical Trial Results: Modest Benefit, Significant Risks
The full approval was based on data from the Phase 3 clarity AD clinical trial, involving nearly 1,800 participants with early-stage Alzheimer’s disease. Results showed that Leqembi slowed cognitive decline by 27% over 18 months compared to a placebo. While statistically significant, experts emphasize this benefit is modest and doesn’t represent a cure. Crucially, the trial also revealed serious risks, including amyloid-related imaging abnormalities (ARIA), which can cause brain swelling or bleeding.
| Outcome | Leqembi Group | Placebo Group |
|---|---|---|
| Cognitive Decline (CDR-SB Score Change) | 0.44 | 0.65 |
| Percentage with ARIA-E (Brain Swelling) | 12.5% | 1.8% |
| Percentage with ARIA-H (Brain Bleeding) | 17.3% | 0.1% |
Who is Eligible for Leqembi?
Leqembi is approved for patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease, and who have confirmed presence of amyloid plaques in their brains – typically verified through a PET scan or cerebrospinal fluid analysis. Patients with the APOE4 gene, a genetic risk factor for Alzheimer’s, are at higher risk of ARIA and require closer monitoring. The FDA requires healthcare providers to be trained in monitoring and managing ARIA before prescribing Leqembi.
Cost and Access: A Significant Barrier
The annual cost of Leqembi is approximately $26,500, before factoring in the costs of required monitoring (PET scans, MRIs) and intravenous infusions. Medicare has announced it will cover Leqembi, but only for patients participating in a registry to track real-world outcomes and safety. This coverage decision is contingent on continued FDA approval and the availability of appropriate diagnostic testing. The high cost and logistical hurdles pose