The Food and Drug Administration (FDA) approved Biogen's aducanumab on June 7, making it the first Alzheimer's medication available in nearly 20 years and the only one that could slow the progression of the disease.
Aducanumab (which will go by the brand name Aduhelm) is not a cure for Alzheimer's, which affects 6.2 million Americans, and it does not reverse it. But data shows the drug is successful at breaking up sticky plaques of protein (amyloid) that accumulate in the brain — a hallmark of Alzheimer's disease. And health officials expect that if the drug can help remove those plaques, it may help slow the rate of cognitive decline in people who are in the early stages of the disease. Other Alzheimer's drugs on the market simply attempt to tackle the disease's debilitating symptoms.
The FDA's approval, however, comes with a condition: The drug's maker, Biogen, which co-developed aducanumab with Eisai, must do further studies to prove the drug works the way it's intended. In the meantime, a few million people suffering from the disease could have access to aducanumab, although the company did announce that the therapy is expected to cost $56,000 a year, and it's not yet known whether public or private insurers will pay for it.
The federal agency that oversees Medicare has initiated a review process to decide if it will cover the drug for beneficiaries — a decision that could cost billions. A Kaiser Family Foundation analysis found that if 500,000 Medicare beneficiaries went on aducanumab, total spending for the drug in one year would be nearly $29 billion. If 1 million beneficiaries receive aducanumab, spending will exceed $57 billion a year.
Patient advocacy groups welcomed the FDA’s June 7 decision. Kristen Clifford, chief program officer for the Alzheimer's Association, called the announcement a “landmark moment” — one that signifies “the beginning of a new future” for people living with Alzheimer's and their families.
"We know that slowing decline, particularly with early diagnosis, could add days, weeks, months, maybe even years of active life for individuals and families,” Clifford said. At the same time, the Alzheimer’s Association has called on Biogen to lower the price of its drug.
First Alzheimer’s drug since 2003 is not without controversy
The historic decision did not come without controversy. Back in November 2020, an FDA advisory committee expressed concern over the clinical trial data supporting aducanumab's effectiveness and essentially voted against approval of the drug.
The concern centered on two identically designed studies that yielded different results. One showed that participants with early or mild Alzheimer’s who were given high doses of aducanumab saw their symptoms decline. They were better able to handle everyday activities, like shopping and paying bills; their memory also improved, Biogen said. But the other study didn’t show the same positive outcomes, and the divergent results have made the drug contentious among experts.
The FDA doesn't have to accept its advisory committee’s vote, but it usually does. This time, however, the agency approved aducanumab through an accelerated process designed to be used for a drug that is significantly better than existing treatments for a serious or life-threatening illness.