The excitement of a new drug, the first in nearly 20 years, to slow dementia was approved by government health officials this week. But many are skeptical that it will work to slow the brain-destroying disease.
“There is more effectiveness in the drug if you’re diagnosed early,” said Debbie Selsavage, president of Citrus County based Coping with Dementia. “But there’s not a lot of people who are diagnosed early on.
Typically, people are diagnosed four to five years after exhibiting symptoms, she said.
The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer's patients.
It’s the only drug now on the market for Alzheimer’s that developers say treats the cause of the disease rather than only the symptoms.
One study showed that the drug only slows the progression of the disease, but does not stop or reverse it. The drug works as an infusion administered every four weeks.
But the new drug, aducanumab, is already being panned by critics as warry as Selsavage.
FDA adviser, Dr. Caleb Alexander, recommended against the drug's approval because of results showing a definitive benefit, according to the Associated Press.
“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a researcher at Johns Hopkins University.
Selsavage said that without a new drug in almost 20 years “there is a sort of desperation that there has to be something.”
Under FDA’s accelerated approval process, the drug maker is required to perform a follow-up study. If the study shows the drug does no good, the federal agency could pull the drug.
Ed Youngblood, marketing and communication director with Coping With Dementia, said the necessity of a follow-up study is not reassuring.
The FDA’s group of outside advising neurologists concluded that, based on a single study that Biogen provided, there wasn’t sufficient evidence that the drug worked.
In 2019, Biogen halted its study because results were not promising, but later began the program again, saying the drug slowed symptoms when administered at higher doses, according to the Associated press.
When it comes to certainty, “the only thing we still have is care,” Selsavage said. “All of the medications (for the dementia) should be used as a supplement to care.”
She said the new drug could help spur on more interest in developing other new drugs for the disease.
The new drug works on plaques and tangles in the brain, a problem many researchers say is associated with, or causes, dementia.
But Selsavage warned that one study showed that 17% of people who were examined after death showed plaques and tangles but no dementia symptoms.
Biogen has not yet announced the price of the drug.
In a statement about the drug, the Alzheimer’s Foundation of America said, “We are hopeful that it will improve the quality of life for individuals living with Alzheimer’s disease and their caregivers.”