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 therapy designed to target and remove amyloid plaques, abnormal protein deposits that accumulate in the brains of people with Alzheimer's disease.
- The Clarity AD trial, a large-scale Phase 3 clinical trial, provided the data supporting the full FDA approval.The trial involved 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 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 significant shift from the previous conditional approval granted in January 2023, and dramatically expands access to the medication for eligible patients. Full approval signifies the FDA has reviewed significant evidence demonstrating Leqembi’s clinical benefit and safety.
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 believed to play a crucial role in the progression of the disease. The drug is administered intravenously every two weeks. Clinical trials have shown that Leqembi can modestly slow cognitive decline, but it is not a cure.
Clinical Trial Results: A Modest but Significant Impact
The Clarity AD trial, a large-scale Phase 3 clinical trial, provided the data supporting the full FDA approval.The trial involved 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 this improvement is not substantial, it represents a meaningful benefit for patients and their families. It’s vital to note that the trial also revealed potential side effects, discussed below.
| Outcome Measure | Leqembi Group | Placebo Group |
|---|---|---|
| Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | 0.44 | 0.65 |
| Percentage of Participants with Amyloid Reduction | 55.3% | 12.3% |
Safety Concerns: ARIA and Monitoring
Leqembi is associated with a risk of amyloid-related imaging abnormalities (ARIA), which can cause brain swelling or bleeding. ARIA is typically detected through MRI scans. The FDA requires healthcare providers to closely monitor patients for ARIA, and the drug’s label includes warnings about this risk. Approximately 12.5% of participants in the Clarity AD trial experienced ARIA-E (edema, or swelling) or ARIA-H (hemorrhage, or bleeding).