The Alzheimer’s Association celebrated on July 6, 2023 to the FDA’s action of approving Leqembi for treatment of early Alzheimer’s for people who showed elevation of amyloid beta. Dr. Joanne Pike, President Of The Alzheimer’s Association, said,” Even though this is not is cure it will give people in the early stages to maintain their independence. People with this fatal disease can discuss choices with their doctor about this treatment.”
Leqembi targets amyloid beta which are plaques in the brain which are a hallmark of Alzheimer’s. In the Phase 3 clinical trial, Leqembi delayed cognitive decline by 5.3 months compared to the placebo after 18 months of treatment. It is administered twice a month through intravenous infusion. Leqembi has been on the market since January 2023. At that time, Medicare blocked coverage of Leqembi. With FDA approval now, it is important for patients to have discussions with both their family and their doctor. Side effects might include temporary swelling or bleeding in the brain which resolves over time. The FDA also recommends genetic testing. Many dementia therapies will be discussed at their international conference in Amsterdam the week of July 16-20.
Leqembi is not a cure but it is used as the first approved treatment that changes the course of the disease for people in the early stages of the disease. The therapy has not been tried on people with more advanced stages or those without any symptoms. It is not able to restore or reverse lost memories. Doctors use medical history, mental status tests, neurological exams, blood tests, and brain imaging. The FDA requires confirmation of beta-amyloid plaques with tools such as a PET scan or lumbar puncture. Your doctor can also use an MRI scan before starting treatment, and they will discuss the risk of ARIA along with genetic testing.
The price of this drug is $26,500 per year. Medicare and Medicaid will cover this as long as the person’s doctor enrols them in a CMS-run registry. People eligible for Medicare can get coverage. Each state may have additional requirements. Infusions are twice per month, one hour long each at hospitals and infusion centres. Side effects in the study were infusion-related reactions, headaches, and ARIA (amyloid-related imaging abnormalities). It is important to talk with your health care provider about medicines you take, vitamins, supplements, and if you take aspirin. No two treatments are the same when targeting beta-amyloid plaques in the brain. Each type works differently and at different stages of plaque formation.