RALEIGH, N.C. (WNCN) — For the first time in nearly 20 years, the FDA has approved a new drug to treat Alzheimer’s disease, and it’s made right here in the Triangle.
It’s the first approved treatment designed to stop the progression of the disease itself, rather than just treat symptoms, and it’s giving a lot of patients and caregivers hope, but doctors warn it’s not a cure and it’s not yet clear how well it works.
When Jay Reinstein noticed some memory issues, at first he blamed information overload. At the time, he was 57 and working as Fayetteville’s assistant city manager. Then the problems progressed.
“There were some really simple questions that I should’ve known and I couldn’t remember,” he recalled.
Doctors diagnosed younger-onset Alzheimer’s disease.
“It really was, as I would say, a punch in the gut,” said Reinstein.
A few years later, he is thrilled to learn the FDA approved a drug designed to slow the progression of the disease. “It honestly gave me chills because we’ve been waiting so long for something,” he said.
Biogen makes the antibody treatment called aducanumab or Aduhelm. The drug is manufactured in the Triangle.
Biogen’s Chief Medical Officer, Dr. Maha Radhakrishnan said, “I feel quite proud that our RTP facility, as we call it, is going to be the facility that’s going to be on point to really bring forward this innovation to our patients in this country.”
Doctors say the treatment, which is given as a monthly infusion, reduces plaques in the brain associated with Alzheimer’s disease, but it’s not clear how well it works to reduce symptoms of cognitive decline.
“What’s more important is how do they think, will they be able to recognize people, will they be able to remember things better?” noted Dr. Heather Whitson, Director of the Duke Center for the Study of Aging and Human Development. “Will they retain their ability to take care of themselves for longer? Those are some of the questions that we don’t have the full answers to yet.”
She added, “What we don’t want to do is take people down a road of false hope. It’s important to understand that this is not a cure and that we don’t know yet what its benefit will be, but we know that it gets rid of the plaques in the brain, and in some patients, it looks like, if they take it long enough and start it early enough, there may be some benefit.”
Reinstein knows the drug may not work for him but spoke in support of it to an FDA advisory committee.
“The message we sent was. ‘Why not?’ Every little bit helps, and this is a baby step,” he said.
“I think it’s the beginning of a new era,” added Whitson. “I think more like this will be coming.”
For now, Reinstein hopes he’ll be able to give the treatment a try. “I’m just crossing my fingers that I’ll have an opportunity to be on that list.”
Even though the FDA approved the drug, it says Biogen must continue studying it to verify whether it does have benefits.
Biogen says the drug could be in the hands of providers in two weeks, but a patient will have to qualify through diagnostic tests.
It’s still not clear how insurance companies will cover the drug.