July 6, 2023 – The FDA today approved a brand new therapy for early Alzheimer's disease that appears to have the potential to barely slow the progression of the disease that affects greater than 6.5 million Americans.
The drug Leqembi targets amyloid plaques in patients' brains, a key feature of the disease. Study data shows it could slow the progression of Alzheimer's disease by 27% inside 18 months.
The drug received accelerated approval in January, which allows the FDA to approve drugs for conditions where there may be an outlined need. It is the primary Alzheimer's therapy to receive full approval from the agency in 20 years. The FDA said the drug has shown “a statistically significant and clinically meaningful” slowing of the disease. There is a risk of brain bleeding and swelling, which might sometimes be fatal, the agency said.
“Today's action is the first confirmation that a drug targeting the underlying disease process of Alzheimer's disease has demonstrated clinical benefit in this devastating disease,” Teresa Buracchio, deputy director of the Office of Neuroscience within the FDA's Center for Drug Evaluation and Research, said in an announcement. “This confirmatory study has confirmed that this is a safe and effective treatment for patients with Alzheimer's disease.”
Medicare said it might cover the drug, which can cost $26,500 annually. But researchers reported in May that Medicare would likely cover only 80 percent of that cost, leaving patients with greater than $5,000 in annual costs. Medicare coverage would also require a patient's doctor to be enrolled in a registry documenting the drug's effectiveness. Some advocates called that an unnecessary barrier to treatment because not all doctors would comply with the registry.
