The FDA is set to decide whether it will fully approve the first Alzheimer’s drug to show it could slow the disease’s progression in certain patients.
But the decision could also have other implications, including who would get access to it.
The FDA is set to decide whether it will fully approve the first Alzheimer’s drug to show it could slow the disease’s progression in certain patients.
But the decision could also have other implications, including who would get access to it. Six years ago, Joe Montminy saw a neurologist for what he thought were a few minor problems with his memory.
“She came back and said, you know what Joe? You actually have younger-onset Alzheimer’s disease. You’re likely going to start to experience declines in the next five years and you may not recognize your family in five to seven years,” Montminy said.
Now 59-years-old, Montminy is one of millions of Americans living with Alzheimer’s disease. But this year, new hope has emerged. A drug aiming to slow down the disease’s progression got accelerated FDA approval in January based on the fact that it clears amyloid plaque buildups in the brain associated with Alzheimer’s.
Medicare declined to cover it until the FDA granted a fuller, traditional approval, based on a bigger clinical trial proving the drug has benefits for thinking clearly and being able to function in daily life. Without insurance, the medicine called Lecanemab and sold under the name Leqembi, costs $26,500 a year.
“You had this treatment at your fingertips and suddenly you had Medicare saying, yeah, but you can’t quite get access to that at this point in time,” Montminy said.
A larger trial, funded by the drug’s makers, Eisai and Biogen, did find that Leqembi can slow the progression of Alzheimer’s disease by about 27%
It’s the first time a drug has proven to alter the disease’s course.
“It was a very dismaying experience getting a diagnosis of Alzheimer’s disease and to be told that all we have is symptomatic medications and that we don’t have anything that will slow down or stop the disease in its tracks,” Dr. Lawrence Hoing with Columbia University said.
Hoing says this is the beginning of a new treatment era.
But he warns that Leqembi is not a cure, and not everyone will be eligible for the drug.
When asked how difficult it will be to refuse the drug to people who are too advanced with Alzheimer’s and may not benefit, Dr. Hoing said, “We’re already having these conversations that sometimes aren’t so easy. It’s not that we know it’s not good for people with moderate or severe disease. It’s just that we don’t know.”
Side effects could be worse for people with more advanced disease as well, he says.
Already, they’re something to be aware of. About 13% of patients receiving the drug in its trial had brain swelling. 17% had brain bleeding, compared with 9% in the placebo group.
Leqembi is administered through IV infusion, once every two weeks. Infusion centers, like Vivo Infusion, are gearing up for an expected surge in new patients.
The CEO of Vivo Infusions expects 15-20% more patient referrals for the drug.
Joe Montminy is hoping he’ll be able to get it, for a chance for more time with his wife and two grown sons. “Like any parent, I would love to see them actually get married and have a family. I just want to experience many of the activities that most people take for granted.”