The FDA Has Approved the First New Alzheimer’s Drug in 18 years. Why Is It So Controversial?

The Food and Drug Administration (FDA) has approved aducanumab (produced by Biogen under the name Aduhelm), the first new treatment for Alzheimer’s disease in 18 years. “This approval is a victory for people living with Alzheimer’s and their families,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement.

But the medication is already surrounded by controversy. The FDA’s independent advisory committee overwhelmingly voted in November against recommending that aducanumab be approved, citing a lack of data to prove that the drug actually slowed cognitive decline. Several members of the FDA’s advisory committee also wrote a viewpoint published in the journal JAMA detailing exactly why they voted against the approval of aducanumab.

Scientists at the nonprofit Institute for Clinical and Economic Review also issued a report in May that said there isn’t enough information to show that aducanumab’s benefits outweigh the potential risks.

Other organizations, including The American Geriatrics Society, also view the approval as “premature given the lack of sufficient evidence to support that aducanumab reduces progression of Alzheimer’s disease,” the nonprofit wrote in a public letter to the FDA.