FDA: Aduhelm Only to Be Given to Early-Stage Alzheimer’s Patients

FDA recently reversed its broad approval for Biogen’s Alzheimer’s drug, Aduhelm, after being approved just last month, according to multiple news outlets. 

The agency now recommends that the drug only be given to early-stage Alzheimer’s patients or patients with mild symptoms after the first 87-year-old patient who received the medication in Chicago saw disease progression.  

FDA said that the drug has not been studied enough in patients with more advanced disease.

In March 2019, Biogen and Eisai discontinued the ENGAGE and EMERGE trials studying Aduhelm based on a futility analysis conducted by an independent data monitoring committee.

ENGAGE did not meet its primary endpoint, and trial results showed that the drug administered as a monthly infusion was not better at slowing memory loss and cognitive impairment than placebo. 

Despite these findings, FDA approved Aduhelm in early June 2021 for all Alzheimer’s patients after years of speculation surrounding the drug. 

Some doctors and scientists saw FDA’s move as premature because they aren’t convinced that the drug works, given the mixed trial results over the years. Approving a drug that’s not effective will set Alzheimer’s research back, critics argue. 

“The mixed response goes back to study of this medication and the study included two legs of the trial, one of them showed some benefits and another one didn’t,” Lenny Cohen, MD at Chicago Neurological Services, told WGN9. 

“We don’t like stuff like that as physicians because it’s kind of cherry-picking data,” Cohen continued. “When you design studies it’s very difficult to predict what kind of outcome you can have. You like to think that you know everything, but you don’t.”

Additionally, Aduhelm comes with a price tag of $56,000 a year. And associated costs, including diagnostics and safety monitoring, could add thousands of dollars to a patient’s yearly bill.

The price tag, combined with the fact that nearly six million Americans with Alzheimer’s disease would have been eligible and are unlikely to benefit from the drug, raised concerns it would have caused an extreme financial burden for Medicare.

Cohen explained that insurance may have to cover the drug because the medication works in a “very unique fashion,” by destroying amyloid plaque.  

The New York Times reported that nearly two million Americans can still receive the drug under the revised drug labeling.