July 6, 2023 – The FDA today 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.”
Medicare said it will cover the drug, which will cost $26,500 each year, although researchers reported in May that Medicare will likely only cover 80% of that cost, passing on more than $5,000 a year to patients. Medicare's coverage will also require a patient’s doctor to participate in a registry that tracks how well the drug works. Some advocates have called that an unnecessary barrier to treatment as not all doctors will agree to the registry.