FDA approves drug shown to slow cognitive decline in early-stage Alzheimer's patients

RALEIGH, N.C. (WTVD) -- The FDA granted traditional approval to Leqembi on Thursday afternoon, a drug that has shown to slow cognitive decline in early-stage Alzheimer's patients.

"For me, it is a game-changer just because we know from the clinical trials that it actually attacks the biology of the disease, and that's what's different from the other medications that were discovered in the 1990s," said Dr. Andy Liu, an assistant professor of pathology and neurology at Duke University.

The drug, which is administered via infusion, was shown to slow the rate of cognitive decline by 27% in a study released last year. While it would not reverse symptoms, Liu explained the importance of delaying the progression of the disease.

"These proteins are toxic to cells in the brain and it causes these cells to die. So the expectation to improve any of the symptoms would be unrealistic. Again, going back to flattening the curve and keeping them where they are, especially if they're in the mild cognitive state, I think it'd be huge," said Liu, who anticipated more patients will utilize the drug now that it's been granted approval.

"I think for the first time it gives you hope. I know it's not a cure. I'm still relatively young. I'm doing well. This is that opportunity. Maybe if it slows down the progression for six months, eight months, a year, that's more time with my wife, my grandkids and my kids. And that's what it's all about," said 62-year-old Jay Reinstein, who was diagnosed with early-stage Alzheimer's in 2018.

Reinstein, who was working as Assistant City Manager in Fayetteville at the time of his diagnosis, has spent the past five years engaging in advocacy. He said he's been fortunate to have experienced a slower progression compared to others, though he noted he struggles with short-term memory loss and is now unable to drive. In anticipation of full approval, Reinstein has already spoken with his doctors about receiving the drug.

"By coming up with some of these new drugs, these new treatments, it will spur other treatments. I think we're in a really good time right now with Alzheimer's treatments," said Reinstein.

Earlier this year, the FDA granted accelerated approvall for the drug, with Thursday's traditional approval opening up access to more patients.

"This new therapy will give families hope. It gives them the ability to age in place longer and spend more time with their friends, their family, and have a better quality of life. This is a great option, and it's just the start of hopefully more therapies down the line," said Heather Hooper, Executive Director of Dementia Alliance of North Carolina.

"It will allow greater access to people so that they can have the ability to remember their loved ones longer to make decisions to be more alert and cognitively sound," said Lisa Roberts, Executive Director of the Alzheimer's Association Eastern North Carolina Chapter.

Despite Thursday's approval, there are still obstacles to access, namely its price and insurance coverage; the annual cost of Leqembi is $26,500.

"It's a big problem, because I don't have that kind of cash that I can just push out for this drug, plus the additional costs. And then you have so many people in underserved communities," said Reinstein, referring to testing needed prior to receiving the treatment.

Last month, the Centers for Medicare and Medicaid announced they would cover the drug, for patients of doctors who participate in a registry. It's a qualification that has received pushback from advocates, who are concerned it could lead to delays in treatment.

"We don't want that to be a barrier for people to get access," Roberts said.

"If we don't cover this drug (through insurance), that (could mean) people living in an assisted living community paying $10,000 a month sooner. We really have to look at the whole picture of what it costs to take care of someone living with dementia, living with Alzheimer's in our community," added Hooper.

The two companies, Biogen and Eisai, behind Leqembi, both have a presence in the Triangle. Biogen has a facility in Research Triangle Park and Eisai has an office in Raleigh.