The FDA approved the drug for people in the early stages of Alzheimer's Disease, but many questions about Aduhelm remain.
For the first time in almost 20 years, the Food and Drug Administration (FDA) approved a new treatment for Alzheimer's Disease. The agency approved the drug aducanumab (Aduhelm) to potentially slow the progression of the devastating illness.
More than 6 million Americans are living with Alzheimer's, which is the most common form of dementia and makes up about 60-70% of all cases. Anyone who has had any experience with the disease knows how traumatic it can be for everyone involved, whether you're a patient, family member, or caregiver.
But what started as good news has turned into controversy. Unclear results, conflicting information, high prices, and a refusal to prescribe from some well-known medical institutions —including the Cleveland Clinic — has resulted in countless questions and an investigation by Congress.
In November, Biogen announced that it was investigating the death of a 75-year-old patient who was taking the drug and developed brain swelling before dying. It is not yet known whether the death was related to the treatment.
Why Is the Approval of Aduhelm Significant?
According to the FDA, Aduhelm targets what is largely considered to be a marker of Alzheimer's — the presence of amyloid-beta plaques in the brain. In a clinical trial, Aduhelm was found to reduce these plaques, which could lead to a reduction of the patient's clinical decline.
The FDA said it "examined the clinical trial findings with a fine-tooth comb" and used its Accelerated Approval program to make its decision. For scientists, this decision opens the door to new research and possibilities.
What's the Controversy?
There were two clinical trials with different results. One found that people who took Aduhelm declined more slowly than those in the placebo group. The other study, however, found that the drug did not help and showed no effect.
There were also side effects. Brain swelling, and in some cases, small brain bleeds, occurred in approximately 40% of cases. About one in four people who experienced brain swelling also noted changes in their vision, mental confusion, headaches, or nausea. Other side effects included falls, loose stool, and possible allergic reactions.
Then there's the price. A year of Aduhelm, which is given by monthly infusion, costs $56,000, and it's not yet clear if Medicare will cover the drug. The agency started a nine-month review process in July.
What Do We Know About the Death So Far?
Dr. Rudy Tanzi, a neuroscientist at Massachusetts General Hospital in Boston, was recently a guest on "The Dr. Oz Show" and noted that numerous hospitals are not prescribing the drug because the high cost "may not be worth" the risks, he said. Still, it is not yet known if the drug had anything to do with the reported death.
Tanzi says that this drug's approval has a "silver lining" — it will open the door for cheaper and safer drugs to be delivered in the future. With Alzheimer's, he says, you need to prevent it decades earlier, like how we treat something like high cholesterol — you want to attack it decades before you need bypass surgery. Tanzi hopes that soon we'll be able to give people amyloid blood tests and start them on treatment earlier, so that in 10 years time, we can "move the dial on the prevalence of Alzheimer's."
Who Is Aduhelm For?
Aduhelm has been approved for people in the early stages of Alzheimer's. Talk to your doctor about your specific case and medical history.
Is There Anything That Can Help Prevent Alzheimer's?
- Perform at least 150 minutes a week of moderate physical activity
- Quit smoking
- Limit alcohol use
- Try a Mediterranean diet, focusing on plant-based foods
- Keep your brain active by picking up new skills, reading books, learning a new dance, and helping others through volunteering
- Keep a social network offline