In today’s Health Alert, a new Alzheimer’s drug may soon be available to millions of Americans living with the disease. An advisory panel to the FDA unanimously agreed that Biogen's treatment drug lecanemab showed clinical benefit and slowed cognitive decline.
This vote paves the way for full regulatory approval, and lecanemab could be the first drug to change the course of this very debilitating disease.
Around 6.5 million Americans have Alzheimer’s. Some of the early signs include problems with memory, difficulty thinking, and trouble with language and completing familiar tasks. For me, personally, I see the impact of Alzheimer’s on a regular basis with patients. And it can be very challenging for patients and their families. That’s why I’m glad the phase three study showed lecanemab was beneficial for slowing cognitive decline.
Right now, lecanemab is restricted. And only patients in a clinical trial, or those who can afford to pay $26,500 a year, can access this drug. It’s a monoclonal antibody given via intravenous infusion on a biweekly basis. It works by binding to amyloid plaques and removing these sticky plaques from the brain. Now the clinical trial included 897 participants who were randomly assigned into two groups. One group was given the new treatment, and the other received the placebo. And after 18 months, researchers found lecanemab slowed disease progression by at least 26%.
In the lecanemab group, the most common serious effects were reactions to the intravenous infusions and brain swelling and bleeding seen on MRIs. The swelling and bleeding is called ARIA – short for amyloid-related imaging abnormalities. And this can become life-threatening. Data showed that 17% of participants had brain bleeding and 13% had brain swelling. Whereas in the placebo group, 9% had brain bleeding and 2% had brain swelling. However, these serious effects tended to happen early during treatment and were resolved by three months. But anyone who gets this treatment needs to be closely monitored.
Now, a decision from the FDA regarding full approval is expected in early July. And not everyone will be a candidate. The treatment was initially granted to those with mild dementia or cognitive impairment. And there is a registry mandate for lecanemab. And while registries are important because they can gather real-world evidence, not everyone – including patients and providers - will want to participate.
