FDA approves new, locally-researched treatment for early Alzheimer's
CONCORD -- The FDA approved the new Alzheimer's drug lecenemab, one of the first drugs that appears to slow cognitive decline in Alzheimer's patients, on Friday.
The treatment, given intravenously, was developed by local pharmaceutical company Biogen with its partner company Eisai in Japan. In Phase 3 clinical trials, it showed the potential for slowing down cognitive decline in patients by up to 27 percent over 18 months.
But experts warn: this is not a magic pill. While lecenemab, or as it will be known commercially, Leqembi, is a far less controversial treatment than its predecessor Aducanemab, it only works in patients in their earliest days of Alzheimer's symptoms or even years before symptoms form. "The odds that a loved one or family member is going to see cognitive improvement in less than 18 months is pretty low," explained Dr. Rudolph Tanzi, the Vice Chair of Neurology at Mass General Hospital. "It's a bit bittersweet," he said. "On the one hand, it's great that the FDA is approving drugs that actually target Alzheimer's pathology, but I think for patients and their families they should know that this drug only has a certain benefit of a very small slice of Alzheimer's patients."
Lecenemab is a monoclonal antibody treatment that targets beta-amyloid, a protein "which forms sticky plaques on the brain and can cause brain cells to die" and is the cause of Alzheimer's, according to the National Institutes of Health.
Lecenemab is not without its challenges: two trial subjects have died, and the drug has caused brain swelling in some patients. Only a small fraction of Alzheimer's patients qualify for the drug (those very early in their cognitive decline). Plus, it costs $26,500 a year.
Still, experts say any progress on the Alzheimer's front, especially approval by the FDA, is an exciting opportunity for future research after years of unsuccessful treatments. "It does open the door for a cheaper, safer drug that can do the same or someday hopefully we will say the FDA, 'let us use those in those 40 million people we need to prevent the disease way before symptoms," Dr. Tanzi said.
The clinical trial for lecenemab was an opportunity for Concord resident Hugh Courtney. The 59-year-old former professor, husband, and father of three was diagnosed with early-onset Alzheimer's in August 2020. "I kind of teetered for a year and a half or two years just trying to figure out what was going on, but eventually realized after a while that that was something real," he explained to WBZ.
When the opportunity to join a clinical trial presented itself, Courtney knew he had to join. "I felt like I just had to, you know?" he said "I can be helpful, even if mine wasn't."
Courtney can't tell necessarily if the drug has actually slowed his cognitive decline, but even so, he says the routine of going to Mass General or McLean Hospital for treatment has been good for his mental health. "It may sound like a small thing, but to me, it's a big thing because I look forward to it," he said.