Last month, the FDA approved a new therapy for early Alzheimer’s disease that appears to modestly slow the progression of the disease that affects more than 6.5 million Americans.
The drug, Leqembi, targets amyloid plaques in patients’ brains, a key feature of the disease. Study data shows it may slow Alzheimer’s progression by 27% over 18 months.
The drug was granted accelerated approval in January, which allows the FDA to approve drugs for conditions when there is a defined need. It is the first therapy for Alzheimer’s granted full agency approval in 20 years. The FDA said the drug “demonstrated a statistically significant and clinically meaningful” reduction in decline from the disease. There are risks of brain bleeding and swelling, which sometimes can be fatal, the agency said.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
The Alzheimer’s Association said in a statement Thursday that it welcomes the FDA’s full approval.
“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,” said Dr. Joanne Pike, the group’s president and CEO. “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.”
More information is sure to follow as more people are prescribed the new drug. It is another step to try to slow down or halt the progression of Alzheimer’s while we all hope and pray that someday, there is a cure.
The full press release from the FDA can be found here: FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval | FDA.
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