The Food and Drug Administration approved aducanumab to treat patients with Alzheimer’s disease Monday morning. It is the first new drug approved by the agency for Alzheimer’s disease since 2003.
The drug is the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer’s disease.
The drug has proved highly effective at reducing the plaques, called beta amyloid, that build up in the brains of people with Alzheimer’s.
But two large studies offered conflicting evidence about whether the treatment slows declines in memory and thinking. A panel of expert advisers to the FDA recommended in November that the agency not approve the drug.
As a condition of approval, the FDA is requiring Biogen, the drug’s maker, to conduct another clinical study to confirm that the reduction of amyloid plaques results in clinical improvement for patients. If the subsequent study doesn’t show a clinical improvement, the agency could move to withdraw the approval.
The medicine will be marketed under the trade name Aduhelm.
Patients will receive the drug in monthly infusions. They will also need regular brain scans to detect a rare side effect: bleeding or swelling in the brain.
Biogen and Eisai, the companies marketing the drug, have yet to announce how much it will cost.