Breanna Reeves |
Roughly 6.5 million Americans 65 years of age and older were living with Alzheimer’s disease in 2022, according to a report by the Alzheimer’s Association. The number of people living with the disease doubles every five years beyond the age of 65.
Among the 65 years and older population in the U.S., 14% of Black people have Alzheimer’s disease, followed by 12% of the Hispanic population and 10% of the White population.
While there is no cure for Alzheimer’s, there are currently five drugs for treatment approved by the U.S. Food and Drug Administration (FDA): donepezil, rivastigmine, galantamine, memantine, memantine combined with donepezil. A sixth drug called aducanumab (Aduhelm), manufactured by Biogen, became the first drug that targets amyloid to be granted accelerated approval by the FDA in 2021.
New hope for early stages
The FDA recently added a seventh drug to the list as of Jan. 6, 2023 with the accelerated approval of leqembi (lecanemab-irmb), manufactured by Eisai and Biogen. Leqembi was granted accelerated approval based on Phase 3 of a randomized, controlled clinical trial. Results from the trial demonstrated the drug’s ability to remove amyloid from the brain, which could allow people in the mild dementia stage of Alzheimer’s to maintain their mental abilities.
“This treatment can change the course of Alzheimer’s in a meaningful way for people in the early stages of the disease, allowing more time to participate in daily life and live independently,” Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer, said in a release.
Alzheimer’s is characterized by the buildup of amyloid which clump together in the brain to form plaques that disrupt cell function. Lequembi, administered intravenously every other week, removes amyloid from the brain.
In Phase 3 of the study of leqembi, a total of 1,795 participants from 50 to 90 years of age with early Alzheimer’s were enrolled — 898 received the drug and 897 received the placebo. The 18-month study found that for 698 participants there were “greater reductions in brain amyloid burden with lecanemab than with placebo.”
“Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events,” the authors wrote in the New England Journal of Medicine. “Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”
Side effects of leqembi are similar to those of aduhelm. Both drugs can cause swelling in the brain or bleeding in the brain, so individuals receiving the drugs will need to be monitored closely. Aduhelm has yet to receive full approval due to controversy regarding the lack of proven effectiveness and dangerous side effects. Medicare is only authorized to cover the drug for patients enrolled in clinical trials as ruled by the Centers for Medicare and Medicaid Services.
Until leqembi receives full approval by the FDA, it is unlikely that Medicare or private insurers will cover the cost of the drug. Eisai will price the drug at $26,500 per year.
Just days after receiving accelerated approval from the FDA, Eisai and Biogen submitted an authorization application of lecanemab to the European Medicines Agency (EMA).