On July 7, 2023, the FDA granted full approval to a new drug for the treatment of early stages of Alzheimer's disease. The drug, called Lecanemab, has been described as a "breakthrough" by experts in the field. It has been shown to slow the progression of the disease by an average of 27% in research studies. However, there are concerns about some rare but potentially serious side effects, such as brain swelling or bleeding, which have prompted the FDA to require a boxed warning on the drug's labeling.
One consideration for patients and their families is the cost of the drug, which is estimated to be $26,500 per year. The drug maker, Eisai, justifies this cost by stating that each patient treated has a $37,600 "per patient per year value" to society.
It is important to note that Lecanemab is not a cure for Alzheimer's disease and does not reverse the progress of the disease in people with more advanced stages. However, it is the first ever traditional approval for a disease-modifying therapy for Alzheimer's disease, which is seen as a significant win for patients and their families.
The drug has been shown to delay symptoms of Alzheimer's disease by more than 5 months compared to a placebo after a year-and-a-half of treatment. This additional time can be valuable for individuals at an early stage, allowing them more time with their families and the ability to continue leading meaningful lives.
However, it is important to be aware of the potential risks associated with the treatment. The drug carries a black box warning, the highest safety-related warning, due to concerns of amyloid-related imaging abnormalities (ARIA) in the brain, which can lead to microbleeds and brain swelling. It is recommended that patients discuss these risks with their doctors, particularly those with a genetic mutation called APOE4, who are at higher risk for these side effects.
Despite the risks, the approval of Lecanemab offers hope for people with early Alzheimer's disease. It addresses the underlying cause of the disease by reducing the levels of amyloid plaques in the brain. Medicare will cover 80% of the drug costs for eligible patients, but there are certain requirements that need to be met, including a diagnosis of mild cognitive impairment or mild Alzheimer's disease dementia.
Looking ahead, there are other drugs in development for Alzheimer's disease, such as donanemab, which is expected to come up for FDA review soon. The ultimate goal is to be able to prevent cognitive decline and dementia by identifying individuals at risk before they develop symptoms.
In conclusion, the full approval of Lecanemab represents a significant advancement in the treatment of early stages of Alzheimer's disease. While it offers hope for patients and their families, it is important to weigh the potential benefits against the risks and consider individual circumstances.