July 6 (UPI) -- The Food and Drug Administration on Thursday approved the first drug proven to slow the progress of Alzheimer's disease.
The drug, Leqembi, which is manufactured by Eisai and Biogen, has been shown to remove from the brain the amyloid plaque that causes Alzheimer's.
Research indicates the drug, which is a monoclonal antibody, slows cognitive decline by 27% in patients in the early stages of Alzheimer's disease.
"This treatment, while not a cure, can give people in the early stages of Alzheimer's more time to maintain their independence and do the things they love," Joanne Pike, DrPH, Alzheimer's Association president and CEO, said in a statement. "This gives people more months of recognizing their spouse, children and grandchildren. This also means more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests."
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Critics of the drug argue the studies showing its effect on cognitive decline are unreliable and that the risk of bleeding within the brain is too high.
Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, told NBC News that slowing the progression of the illness falls below the threshold of what would be "noticeable" to a patient.
"The odds for brain swelling and hemorrhage are far higher than any actual improvement," said Espay, who launched a petition in June calling for the Alzheimer's treatment to not get full approval.
In 2021, the Centers for Medicare and Medicaid Services only approved insurance coverage for a prior Eisai and Biogen Alzheimer's drug, Aduhelm, for patients participating in the trials.
In January, the drug was fast-tracked due to promising trials. It is given as an IV infusion once every two weeks.
"I don't think we can understate the significance of this moment," Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky, said according to NBC News.
Eisai said that it will likely take a few years for people with the disease to seek out the drug.
"You're going to have a much, much lower number, at least at this moment," Eisai U.S. CEO Ivan Cheung said, according to CNN. "Maybe a few years down the road, as these therapeutic options are available, these testings are reimbursed, that number will go up more, but I don't think you're going to see a million people in the next couple of years."
