The Food and Drug Administration (FDA) has approved aducanumab, a monoclonal antibody, to treat Alzheimer’s disease. Aducanumab is the first drug to be approved for Alzheimer’s disease in over 20 years. The drug is expected to cost $56,000 per year.
Aducanumab is designed to target amyloid plaques, which are thought to be a hallmark of Alzheimer’s disease. The drug was approved under the FDA’s accelerated approval pathway, which allows for the approval of drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
In the clinical trials that led to the approval of aducanumab, patients who received the drug showed a slowing of cognitive decline compared to patients who received a placebo. However, the clinical trials were also criticized for their design and for the fact that the drug did not show a significant improvement in overall function in patients with Alzheimer’s disease.
The approval of aducanumab is a major development in the fight against Alzheimer’s disease. However, it is important to note that the drug is not a cure for Alzheimer’s disease and it is not clear how long it will be effective in slowing the progression of the disease.
The drug was approved for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. The drug is administered by infusion every four weeks. The most common side effects of the drug are headache, amyloid-related imaging abnormalities (ARIA), and infusion-related reactions. The drug is not recommended for patients with severe Alzheimer’s disease or with a history of ARIA.
The approval of aducanumab is a hopeful sign for the millions of people who are affected by Alzheimer’s disease. However, it is important to remember that the drug is not a cure and it is not clear how long it will be effective in slowing the progression of the disease. More research is needed to develop more effective treatments for Alzheimer’s disease.