New FDA Drug Approval for Alzheimer’s Disease
By Jasen Chau, PharmD, AAHIVP, APh, Assistant Professor, School of Pharmacy
In an effort to stem the progression of a disease that affects more than six million Americans, pharmaceutical companies have labored through a long series of unsuccessful clinical trials in the past using amyloid-targeting medications to help treat patients with Alzheimer’s disease. Despite conflicting findings from clinical trials, Biogen’s Aduhelm became the first amyloid-targeting medication to be approved in 2021. Although there was controversy among some experts on the treatment’s safety and effectiveness, the Food and Drug Administration (FDA) and regulators approved another medication for Alzheimer’s that appears to halt the brain disorder. Lecanemab, a medication that works on the amyloid beta, was the subject of an accelerated FDA approval request from Eisai and Biogen. Lecanemab functions by attaching to and neutralizing amyloid “protofibril” clusters in the brain. The late-stage trial was the most recent to evaluate a thirty-year-old hypothesis that amyloid builds up in Alzheimer patients’ brains and causes the illness, which can be slowed by medications that prevent this protein buildup. Patients with mild or early-stage disease, who were the subjects of the clinical studies, are the target group for the treatment.
Lecanemab has shown effectiveness at slowing cognitive decline in a late-stage clinical research of 1,795 participants who received the medication or a placebo. In contrast to other amyloid-targeting medications that have failed in significant studies, the drug reduced cognitive decline by 27% in the phase 3 clinical trials when compared to placebo. Over the course of 18 months, participants either received a placebo or a dose of 10 mg per kilogram, every two weeks. People using the medication were more likely to have brain edema and a little bleeding. The cost of Lecanemab, marketed under the trade name Leqembi, for biweekly dosing, is around $26,500 per year. Lecanemab’s approval was decided following some critical congressional reports on the prominent drug, Aduhelm. There are many unanswered clinical questions yet to be concluded with Aduhelm. However, these newer drug approvals will certainly be part of the conversation to help people diagnosed with Alzheimer’s disease and their families.