• Posted January 31, 2024

Biogen Is Dropping Controversial Alzheimer's Drug Aduhelm

Biogen, maker of the Alzheimer's medicine Aduhelm, announced Wednesday that it would "discontinue the development and commercialization" of the controversial drug.

Biogen will return the rights to Aduhelm to Neurimmune, the private firm that invented it, the company said in a statement.

It's a sobering new chapter for the drug, which first gained U.S. Food and Drug Administration approval in 2021. Some hailed Aduhelm as the first new medication for Alzheimer's disease in decades.

But many others questioned Aduhelm's safety and effectiveness, and Medicare refused to cover the drug's high cost because of doubt over its effectiveness. Initially, a year's supply of Aduhelm was priced at $56,000, but after widespread criticism Biogen cut that price in half.

The drug still has its supporters. In a statement, the Alzheimer's Association (AA) called Aduhelm's 2021 approval "a landmark event for the Alzheimer's field and, most importantly, [it] provided hope for the millions of people living with early Alzheimer's, and their families."

The AA put some of the blame for Aduhelm's downfall on federal agencies.

The U.S. Centers for Medicare and Medicaid Services "denied Medicare coverage to this treatment -- approved by the FDA using the accelerated approval pathway -- unless the patient was enrolled in a clinical trial," the AA said. "We believe this contributed to limiting the number of people living with Alzheimer's, a fatal disease, who could get access to the approved treatment, and created significant confusion for patients and doctors."

For its part, Biogen said it will shift its focus to a newer Alzheimer's drug, Leqembi, which it markets in a partnership with Japan-based Eisai. Leqembi received FDA approval last year.

For people still taking Aduhelm, the AA had some advice.

"The Alzheimer's Association recommends that people receiving Aduhelm through a clinical trial or by prescription, and their families, should connect with their study contact and/or their personal health care provider to talk through how these changes will impact their treatment and care," the organization said.

More information

The U.S. Centers for Disease Control and Prevention has more on Alzheimer's disease.

SOURCES: Biogen Inc., news release, Jan. 31, 2024; Alzheimer's Association, news release, Jan. 31, 2024