Aducanumab (Aduhelm) is a drug for Alzheimer’s disease with mild cognitive impairment. The FDA approved it faster than usual -- and against the recommendation of its own advisory panel. That’s led some medical experts to question whether more research is needed about the drug’s safety and effectiveness.
Here’s a look at what Aduhelm does, its side effects, costs, and more.
How Does Aduhelm Work?
It’s a drug that you get once a month through a needle in the vein (IV) as an infusion. You may need to take it for the rest of your life.
Aduhelm targets a key sign of Alzheimer’s disease: plaques of a protein called amyloid-beta, which builds up in the brain and can lead to the death of neurons.
When Aduhelm attaches itself to amyloid-beta plaques, your body’s defenses respond by getting rid of them. Scientists think this might keep brain cells from dying and stop your memory and thinking from getting worse.
What Does the Science Say?
Two large studies looked into Aduhelm’s effectiveness. Both lowered the number of beta-amyloid plaques. One found that high doses of the drug slightly slowed -- but didn’t stop or reverse -- troubles with thinking, memory, and the ability to function. The other study didn’t show a benefit and was stopped early.
That one successful study wasn’t enough to win over the FDA advisory panel, but the agency decided to move forward. It gave Biogen, the company that makes Aduhelm, 9 years to confirm the drug’s possible benefit in a “post-approval” study.
The FDA has launched an investigation into its decision-making process because of concerns about the drug’s fast approval. And some hospital systems have decided they won’t give Aduhelm to patients until there’s more research to show it’s safe and effective.
What Are the Side Effects?
Some side effects of Aduhelm are:
How Much Does It Cost?
You might have to pay about $56,000 per year for Aduhelm, along with other fees for things like imaging scans and blood tests.
Could It Be Right for Me?
That’s a question you can answer only with a doctor’s help. If you’re interested in trying Aduhelm, ask your doctor to explain the pros and cons.