Leqembi: A Turning Point in Alzheimer's Treatment
On January 6, 2023, the U.S. Food and Drug Administration (FDA) made a significant step forward in Alzheimer's treatment by initially approving Leqembi via the Accelerated Approval Pathway. This was followed by a traditional approval on July 6, 2023.
What is Leqembi?
Leqembi, also known as lecanemab-irmb, is an amyloid beta-directed antibody designed for the treatment of Alzheimer's disease. The FDA initially granted it accelerated approval on January 6, 2023. This form of approval is utilized for drugs that fill an urgent medical need, based on clinical data that demonstrates the drug's effect on a surrogate endpoint. In Leqembi's case, this was the reduction of amyloid plaques in the brain, which are a hallmark of Alzheimer's disease. Following this, on July 6, 2023, the FDA granted traditional approval to Leqembi. This transition to traditional approval was based on a confirmatory trial that verified the clinical benefit of the drug.
Leqembi's efficacy was evaluated in a Phase 3 randomized, controlled clinical trial, which demonstrated a statistically significant and clinically meaningful reduction in cognitive decline in patients with Alzheimer's disease. It should be noted that the drug is indicated for use in patients with mild cognitive impairment or mild dementia stage of the disease, and there are no safety or effectiveness data on initiating treatment at earlier or later stages than those studied.
Learn more about Alzheimer's Disease
How does Leqembi work?
Leqembi is designed to target and remove beta-amyloid plaques in your brain. Beta-amyloid is a protein that accumulates and forms plaques in the brains of those with Alzheimer's disease. These plaques are considered one of the key pathological features of the disease and are believed to contribute to the cognitive decline and neurological damage seen in Alzheimer's patients.
The drug works by binding to these plaques and aiding the immune system in clearing them from the brain. This process aims to lessen the plaque burden and potentially slow down or halt the progression of Alzheimer's disease.
Regarding eligibility for Leqembi, it is important that patients have a confirmed presence of beta-amyloid plaques in the brain, as the drug specifically targets these plaques. Therefore, tests such as brain MRIs are conducted to confirm their presence before starting treatment.
Clinical trials have shown promising results for Leqembi. In a significant Phase 3 clinical trial involving 1,795 participants with early-stage, symptomatic Alzheimer's, lecanemab slowed clinical decline by 27% after 18 months of treatment compared to those who received a placebo. This result indicates a notable reduction in the likelihood of progressing to more advanced stages of Alzheimer's over this period. The trial also reported a 26% slowing in cognitive decline and a 37% slowing in decline in daily living activities compared to the placebo group.
Currently, Leqembi has been approved solely for the treatment of mild stages of Alzheimer's disease. There is no available data to indicate its effectiveness in more severe stages of this condition.
Administration
Leqembi is administered as an intravenous (IV) infusion, given every two weeks. The process involves a healthcare provider slowly infusing the medication into the patient's body over approximately one hour. Due to the nature of IV infusion, Leqembi cannot be self-administered; it requires administration by a healthcare professional in a clinical setting like a hospital or infusion center. The dosage of Leqembi is calculated based on the patient's body weight to ensure proper treatment levels are administered.
Regarding the cost of Leqembi, the drug's annual price has been set at approximately $26,500. This pricing decision was made by the manufacturers of Leqembi. For coverage, the Centers for Medicare & Medicaid Services (CMS) have indicated that they will provide coverage for the drug, provided that a patient's physician enrolls them in a CMS-managed registry. This decision is part of the effort to ensure that patients who need this treatment have access to it under their healthcare plans.
Side Effects
Leqembi, a medication for Alzheimer's disease, has certain side effects that patients should be aware of:
- Amyloid-Related Imaging Abnormalities (ARIA): This is a key side effect of Leqembi. ARIA often doesn't show noticeable symptoms but can sometimes be serious. It mainly involves swelling in certain areas of the brain and can sometimes include small spots of bleeding on the brain's surface. Though this swelling usually goes away over time, some people might experience symptoms like headaches, confusion, dizziness, vision changes, nausea, or even seizures.
- Risk for People with Specific Genetic Factors: People who carry the ApoE ε4 gene may have a higher risk of experiencing ARIA. That's why doctors often recommend a genetic test before starting Leqembi to assess this risk.
- Infusion-Related Reactions: When Leqembi is given via an IV infusion, some people might have reactions like difficulty breathing, dizziness, nausea, fever, chills, and a feeling of a pounding chest. These symptoms are related to the infusion process itself.
Interactions
As of now, there are no specific reports from the manufacturer of Leqembi about how this medication interacts with other drugs. This means that more research and studies are needed to fully understand if and how Leqembi might interact with other medications you might be taking.
When considering Leqembi as a treatment option, it's crucial to have a detailed conversation with your doctor. They will evaluate if Leqembi is suitable for you, especially in relation to any other health conditions you have, and medications or supplements you are currently taking. It's important to give your healthcare provider a complete picture of your health, including all prescription and over-the-counter drugs, vitamins, and herbal supplements. This will help them make the best decision for your treatment plan and ensure your safety.