Summary
The antibody aducanumab this week became the first new Alzheimer’s disease drug approved in the United States since 2003, and the first ever that aims to interfere with the underlying disease process. In a controversial decision, the U.S. Food and Drug Administration overruled its advisers to approve aducanumab, an intravenously delivered antibody developed by Biogen and marketed as Aduhelm, based on evidence that it clears a toxic form of the protein beta amyloid, which accumulates in the brains of people with Alzheimer’s and is widely thought to drive neuronal damage. The decision came despite thin and conflicting evidence from two large clinical trials about the drug’s ability to slow patients’ cognitive decline.
