On 7 June 2021, FDA granted immediate approval. to aducanumab (brand name Aduhelm), the primary drug in 18 years for Alzheimer's disease. The FDA has since modified the unique approval language to recommend that or not it's used only in certain patients with mild cognitive impairment or early Alzheimer's disease.
Concerns about FDA approval of Aduhelm have prompted further investigation into its safety, effectiveness, and price. Some insurers are refusing to cover it and a few medical centers have decided to not prescribe it.
How does the drug work?
Adocanumab (Brand name Adohelm) is a monoclonal antibody that has been designed in a laboratory to bind to the amyloid molecule that forms plaques within the brains of individuals with Alzheimer's. Most researchers imagine that plaques form first and damage brain cells, causing tau tangles to form inside them, killing the cells. Once aducanumab sticks to the plaque, your body's immune system will step in and take away the plaque, considering it's a foreign invader. The hope is that, once the plaques are removed, the brain cells will stop dying, and considering, memory, functions and behavior will stop deteriorating.
Who is a candidate for Aducanumab?
Based on the clinical trials during which it was studied, this drug could potentially be considered to be used in individuals with early-stage Alzheimer's disease. This means individuals who have Alzheimer's in its mild cognitive impairment or mild dementia stage. People on this early stage of Alzheimer's may have the ability to operate normally, or they might need just a little help with complex activities like paying bills, searching for groceries, preparing meals, or balancing their checkbook. . Individuals who require assistance with dressing, bathing, or other basic activities could be beyond the initial stage and the drug wouldn't be indicated for them.
Note that not everyone with mild cognitive impairment or mild dementia will develop Alzheimer's disease. There are other reasons for these problems. To determine if Alzheimer's is present, it is advisable to have an amyloid PET scan or a lumbar puncture to make sure that you've Alzheimer's amyloid plaques. Currently, a lumbar puncture is frequently covered by insurance, but an amyloid PET scan (costing about $5,000) is just not.
How do you're taking the medication and is it protected?
To take the drug, you would like an intravenous infusion every 4 weeks — ceaselessly. Thirty percent of those that took the drug had severe brain swelling, and greater than 10 percent had bleeding from the brain. These unwanted effects require close monitoring by a specialist neurology/radiology team who understand learn how to monitor for these events and know when to withhold or discontinue the drug.
How much does it cost and the way soon can I get it?
Biogen, the corporate that makes adocanumab, estimates the price at $56,000 a yr. It is just not yet clear whether Medicare, Medicaid, or private insurance firms pays for the drug. on this News for the newspaper, Biogen noted that it's working on an agreement with the Veterans Health Administration to cover the drug for veterans enrolled in VA health care. Aducanumab is just not currently available, but the corporate is working to make the drug available soon, perhaps inside a couple of months.
But does the drug work?
I reviewed this in a previous blog post. Publicly available data and a day-long FDA hearing on aducanumab. Briefly, there have been two large clinical trials to evaluate the effectiveness, unwanted effects, safety, and the way the drug might be utilized in clinical practice. One of the studies was positive, meaning the drug worked to slow the decline in considering, memory and performance that is frequently not possible to stop in Alzheimer's. Another large study was negative. In my view—and that of the FDA Advisory Panel—those results mean we don't know if the drug works.
Another factor to think about is that the potential profit — if the drug works because it did within the positive study — was quite small. Looking at two objective measures, within the positive trial, the high dose produced a 0.6 point change on the 30-point mini-mental state test. On the 85-point Alzheimer's Disease Assessment Scale–Cognitive subscale-13, the high dose resulted in a 1.4-point change.
Talk to your doctor.
Should you or a loved one take adocanumab? You should discuss this decision together with your doctor. Because we don't know if aducanumab works, deciding to take it's like deciding to take part in a clinical trial. As mentioned above, known unwanted effects are that 30% of individuals experienced reversible brain swelling and greater than 10% experienced a small bleed on the brain. Although it clears amyloid plaques from the brain, we don't know if it can reduce dementia.
Explanation in the longer term
Part of the FDA's approval of adocanumab requires Biogen to conduct an extra study to try to find out if it actually works. So, we could have more clarification in the longer term. However, this extra study will likely take three to 4 years, and thus the outcomes shall be too late for those trying to make a decision whether to take the drug today.
Which everyone can do today.
My hope is that this drug will work to slow Alzheimer's and reduce the suffering it causes to individuals and their families. We should note that other FDA-approved medications for Alzheimer's (resembling donepezil, galantamine, and rivastigmine) might also be helpful, as can controlling blood pressure, engaging in aerobic exercise, eating a Mediterranean food regimen. Eating a menu, being socially lively, having a positive attitude, and using Memory strategy.