Local reaction to new controversial FDA-approved Alzheimer’s drug
RICHLAND, Wash. — In a historic move in the fight against Alzheimer’s Disease, the Food and Drug Administration (FDA) controversially approved the first new drug in over twenty years on Monday.
It’s called aducanumab but will be marketed as Aduhelm. The drug was created by Biogen in Cambridge, Massachusetts, and Japan’s Eisai Co.
The approval came under the FDA’s accelerated approval pathway. This allows “for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments,” according to a news release.
It’s the only drug on the market that targets the fundamental pathophysiology of the disease since it helps clear a protein called beta-amyloid from the brain. Officials said it will be given by infusion every four weeks.
Researchers evaluated Aduhelm’s efficacy in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease. Patients receiving the treatment had a significant dose-and time-dependent reduction of amyloid-beta plaque, while patients in the control arm of the studies had no reduction of amyloid-beta plaque, the release said.
“We were very happy about the approval for this medication and it was something that we had been asking to happen for a while now,” said Joel Loiacono, the regional director for Eastern Washington and North Idaho’s Alzheimer’s Association. “It’s not a cure but it’s definitely a step forward.”
Currently, Alzheimer’s affects over six million people in the United States. In Washington, the disease is the third leading cause of death.
One of the thousands of people experiencing Alzheimer’s in the state is 71-year-old David Brown, who was diagnosed in 2015.
“I knew that I was in trouble. I was confused, I couldn’t drive a car. I wanted to cross the street and there’s a traffic light and I couldn’t remember what the traffic light meant,” Brown said.
The Richland resident said he applied for Aduhelm’s clinical trials right after he was diagnosed, despite warnings of potential side effects.
“I read all the material about the microhemorrhages and the risk from that and I said ‘it’s worth it,'” Brown said. “I was going to do it and it’d mean trips across the mountains once or twice a month for 18 months and getting a lot of MRI’s and infusions, but I was on board.”
Brown said that in some ways it felt like he was “grasping at straws” after he learned of his diagnosis and he hopes this drug will help others.
“The thing I look forward to most is this as a pathway to learning more about the disease and learning what else we can do and how this would work with other remedies because there are so many parts of the disease that can be addressed,” Brown said.
However, the decision to approve the drug is controversial. The FDA’s independent advisory committee recommended against the approval, citing a lack of evidence ineffectiveness.
“The approval also came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed the drug was effective,” according to this article by the Associated Press. “Biogen halted two studies in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.”
The FDA said it approved the drug on the condition that Biogen conducts a follow-up clinical study proving its effectiveness. If the study fails, the FDA said it would withdraw the drug from the market, a move that is rare.
Brown said he believes a “cocktail of medicine and lifestyle changes” will potentially be the key to both preventing and slowing down the disease.
“Aerobic exercise is essential and good sleep every night is critical to how Alzheimer’s starts and unfolds,” Brown said. “A healthy diet is important from the standpoint of inflammation to the brain and also fighting oxidation.”
All of those things are what Brown believes “bought him 10 more years.” Now, he wants to spread that message to younger folk who have the time and chance to prevent the disease.
“These last few years of my life have been the most exciting years of my life just learning about it and finding out that people are willing to listen to me and sharing what I’ve known,” Brown said. “I know I’m not cured but it makes me feel excited. It makes me want to get up in the morning.”
You can check out Brown’s book about his experience with Alzheimer’s here.
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