Tap to explore
The FDA gave fast approval to aducanumab (brand name Aduhelm) on June 7, 2021, the first treatment for Alzheimer's disease in 18 years. Since then, the FDA has changed the approval's original language to recommend that it be used exclusively in specific individuals with mild cognitive impairment or early Alzheimer's disease. Concerns over Aduhelm's FDA approval have prompted more research into its safety, effectiveness, and cost. Some insurance companies refuse to cover it, and some medical institutes refuse to prescribe it.
Aducanumab (Aduhelm) is a monoclonal antibody that was developed in a lab to bind to the amyloid molecule that causes plaques in Alzheimer's patient's brains. The plaques, according to most researchers, form first and harm brain cells, prompting tau tangles to form inside them, eventually killing the cells. When aducanumab binds to the plaque, your body's immune system attacks it, mistaking it for a foreign invader and removing it. The goal is that after the plaques are removed, the brain cells will stop dying, and thinking, memory, function, and behavior will improve.
The medicine could be investigated for treatment in people with early-stage Alzheimer's disease based on the clinical trials that were conducted. This refers to people with Alzheimer's disease who are in the early stages of the disease, such as moderate cognitive impairment or mild dementia. Individuals with Alzheimer's disease who are in the early stages of the disease may be able to function normally, or they may require assistance with more complex tasks such as paying bills, grocery shopping, cooking, or balancing their checkbooks. Individuals who require assistance with dressing, bathing, or other basic functions are not in the early stages of the disease, and the medicine is not recommended for them.
To take the medicine, you must receive an intravenous infusion every four weeks for the rest of your life. Thirty percent of those who took the medicine experienced reversible brain enlargement, and more than ten percent experienced small brain bleeds. These side effects must be properly monitored by a neurology/radiology team that knows how to see them and when to pause or stop taking the medication.
The cost of aducanumab is estimated to be $56,000 per year by Biogen, the company that manufactures it. It's unclear whether this prescription will be covered by Medicare, Medicaid, or private insurance.
In a nutshell, two big clinical trials were conducted to evaluate the drug's effectiveness, side effects, and safety, as well as how it might be utilized in clinical practice. One of the studies came back positive, indicating that the medicine helped to reduce the decrease in thinking, memory, and function that is so common in Alzheimer's disease. The results of the other large trial were negative. These findings, in my opinion — and that of the FDA advisory council — indicate that we don't know whether the medicine works or not. Another point to consider is that the potential benefit — if the medicine performs as well as it did in the positive research — is rather minor.