Matt York / AP
The Food and Drug Administration on Monday morning approved aducanumab to treat patients with Alzheimer’s disease. It is the first new drug approved by the Alzheimer’s disease agency 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 been shown to be very effective in reducing plaques, called beta-amyloid, that build up in the brains of people with Alzheimer’s disease.
But two large studies have offered conflicting evidence as to whether treatment slows the decline in memory and thinking. A group of expert FDA advisers recommended in November that the agency not approve the drug.
As a condition of approval, the FDA is asking Biogen, the drug’s maker, to conduct another clinical study to confirm that reducing amyloid plaques leads to clinical improvement for patients. If the following study does not show clinical improvement, the agency may withdraw the approval.
The drug will be marketed under the trade name Aduhelm.
Patients will receive the drug as 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 that market the drug, have yet to announce its cost.