In Other Journals: Science
- The food and Drug Administration (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...
- Leqembi is an antibody therapy designed to target and remove amyloid plaques, a hallmark of Alzheimer's disease, from the brain.
- 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.
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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 conventional 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 determined the drug’s benefits outweigh its risks, based on comprehensive clinical trial data.
Understanding Leqembi and How It Works
Leqembi is an antibody 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.
Clinical trial Results: What the data Shows
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. results showed 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 risks, including amyloid-related imaging abnormalities (ARIA), which can cause brain swelling or bleeding.
| Outcome Measure | Leqembi Group | Placebo Group |
|---|---|---|
| Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | 0.44 | 0.65 |
| Percentage of Participants with ARIA-E (edema) | 12.5% | 1.8% |
| percentage of Participants with ARIA-H (hemorrhage) | 17.3% | 8.7% |
Who is Eligible for Leqembi?
Leqembi is approved for individuals with mild cognitive impairment or mild dementia stage of Alzheimer’s disease,and who have confirmed presence of amyloid plaques in the brain. Confirmation of amyloid presence requires a PET scan or cerebrospinal fluid analysis. Patients must also be monitored for ARIA with regular MRI scans. The drug is not suitable for individuals with advanced Alzheimer’s or other forms of dementia.
The annual cost of Leqembi is approximately $26,500, before insurance coverage. Medicare has announced it will cover Leqembi for eligible patients enrolled in the clarity AD clinical trial and, following a National Coverage Determination (NCD), for a broader population meeting specific criteria.However, access remains a significant hurdle due to the need for specialized diagnostic testing, infusion centers, and ongoing monitoring. The infrastructure to support widespread Leqembi administration is still being developed.