A new medication has been made available to patients with early-stage Alzheimer’s since it was proven to slow the disease’s progression. Brand name Leqembi, or generic lecanemab, is a different type of medication from traditional Alzheimer’s treatments, which typically only target symptoms and not the disease itself.
In January 2023, the drug received approval from the Food and Drug Administration through the accelerated approval pathway, a program which allows drugs for serious conditions to be fast-tracked for approval when there is an unmet medical need the drug can satisfy.
According to the Food and Drug Administration, researchers at Eisai Research and Development Management spent 18 months studying 1,795 patients with early-stage Alzheimer’s. While half of the patients received a placebo, the others were given significant doses of 10 milligrams/kilogram every two weeks via intravenous transfusion. By week 79, the drug had been statistically shown to reduce brain amyloid plaque, which causes Alzheimer’s.
Eisai Research and Development Management Company is a leading global research and development-based pharmaceutical company established in 1941 and headquartered in Japan. The main goal during the drug’s development was to slow the progression of the currently incurable Alzheimer’s.
Like any drug, Leqembi isn’t without side effects and risks. Some of the most common are serious allergic reactions, infusion-related reactions and headaches. Another occasional side effect found includes possible brain swelling and bleeding in patients with amyloid-related imaging abnormalities (ARIA).
According to NBC, medical professionals have concerns over the statistics on these brain swells and bleeds. There is a significant percentage gap for people who experience these symptoms
depending on whether they took Leqembi or a placebo. For those who took the placebo in clinical trials, 1.7 percent of patients had brain swelling and 9 percent had brain bleeding. For Leqembi patients, 12.6 percent experienced brain swelling and 17 percent experienced brain bleeding.
Medical professionals believe these symptoms are a byproduct of how the drug works. Leqembi removes the amyloid plaque from the walls of the blood vessels, which can make the brain leaky. The benefit-to-risk ratio has caused concern among some medical professionals as the risk level is not always predictable with Leqembi. Experts worry more may be uncovered over time as it remains unclear if brain swelling or bleeding will worsen the longer a patient takes Leqembi.
There is yet to be a study on whether this drug is effective for people with more advanced stages of the disease, and the medication has only been recommended to people diagnosed with early-stage Alzheimer’s and Mild Cognitive Impairment (MCI).
Leqembi has not been proven to restore or reverse lost function or memories. According to the Alzheimer’s Association, Leqembi is the first traditionally approved treatment that addresses the underlying biology of Alzheimer’s and changes the course of the disease in a meaningful way for people in the early stages.
Unfortunately, Leqembi comes with a sizable price tag of about $26,500 per year, making it cost prohibitive for many patients.
The diagnostic tests required by the FDA and practiced by medical professionals determine if someone has Alzheimer's and qualifies for Leqembi. These tests include medical history, mental status testing, physical and neurological examination, brain imaging and biofluid tests.
Patients who feel they may be a good candidate for Leqembi should speak with their doctor to determine whether the drug may be effective for them.
While its cost and possible side effects may give patients and their care providers pause, Leqembi is unique in how it targets Alzeimer’s. The drug also offers optimism for patients who are faced with an incurable disease, and is evidence of steps being made in the right direction.
Mike Maynard is an editorial assistant for CityScene Media Group. Feedback welcome at feedback@cityscenemediagroup.com.
