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Alzheimer’s Drug Leqembi Receives Full FDA Approval, Expanding Access to Treatment
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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. Full approval signifies the FDA has determined the drug’s benefits outweigh its risks, based on thorough 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 disease. 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 disease. 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 in later stages of the disease.
The annual cost of Leqembi is approximately $26,500,before insurance coverage. Medicare announced in July 2023 that it will cover Leqembi for eligible patients, but with specific requirements, including participation in a registry to track outcomes and safety. Access to the drug may also be limited by the availability of specialized infusion centers and the need for regular MRI monitoring. Eisai is offering a patient support program to assist with navigating insurance and financial assistance.
Potential Side Effects and Risks
The most common side effects of Leqembi include infusion-related reactions, such as fever, chills, nausea, and vomiting. More serious risks include ARIA, which can lead to brain swelling or bleeding. Individuals with the APOE4 gene variant, a genetic risk factor for Alzheimer’s, may have a higher risk of developing ARIA. Careful monitoring and management are crucial for mitigating these risks.
