PRAIRIE VILLAGE, Kan. — This week the FDA approved the first new Alzheimer’s drug in nearly two decades. It’s billed as the first to slow onset of the cognitive disease affecting millions of Americans.
But that approval wasn’t without controversy.
At one point aducanumab studies were halted because of side effects include micro brain hemorrhages. But now it’s gained accelerated FDA approval and the Alzheimer’s Association and one Kansas clinical drug trial participant couldn’t be more excited.
For 25 years, David Welch has lived with Alzheimer’s in his family. First his dad, then his sister.
“It’s very hard. It’s a very brutal disease. Most of the time my dad was in very good health, but terrible mental health. At the end he couldn’t remember to chew,” Welch said.
Then three months after Welch turned 60, a neural psych exam revealed he had dementia. In 2015, his doctor found a clinical study for aducanumab.
“It’s changed my life, my dad and my sister couldn’t drive anymore or fill out prescriptions after 3 years. I’m 6 years in and I’m working and driving and enjoying my family and traveling,” Welch said.
That drug just received FDA approval for people with mild cognitive impairment or early stage Alzheimer’s to help remove one of the hallmark signs of Alzheimer’s, an amyloid plaque on the brain.
“This is actually the first drug that will slow Alzheimer’s disease. So this is definitely the beginning of a completely new future,” Briana Tucker, a research champion for the Alzheimer’s Association, said.
Patients are treated with monthly infusions and also multiple MRIs to check for progress and possible side effects. During the year Welch had to stop using the drug while it’s effectiveness was studied, he said he got worse. But now , 6 years after his diagnosis, after renewing treatment, he says he does better on cognitive tests than when he started.
“I think it’s amazing. It’s going to help a lot of people. It can’t help everybody, but it is going to be very good for a lot of people,” Welch said.
The FDA could still pull approval if ongoing studies, which Welch will be involved in, don’t prove removing the plaque helps patients.
The Alzheimer’s Association says it’s receiving questions about the drug and encouraging people to speak with their doctor to find out if they might be a good candidate.
“We all want more time and we are very excited and hopeful this drug will give people more time to enjoy life,” Tucker said.
The manufacturer Biogen is ramping up production and will sell it under the name Aduhelm. What’s still unclear is if the cost, which could be as much as $56,000 a year, will be covered by insurance or Medicare?