FDA’s Approval Of Debated Alzheimer’s Treatment Raises Controversy

This week, the FDA gave the green light to a drug for the treatment of Alzheimer’s disease. The drug, a monoclonal antibody called aducanumab, is the first Alzheimer’s treatment to receive approval in almost 20 years. It targets the amyloid protein that forms the tangled plaques found in the brains of people with Alzheimer’s. But while researchers agree that aducanumab leads to less amyloid plaque, no one really knows what that means in terms of real benefits for people with the disease.

Researchers still don’t understand the role of amyloid in the progression of Alzheimer’s disease—and in two studies conducted by the company Biogen, only one showed taking aducanumab provided a slight cognitive benefit to people with early Alzheimer’s. The other study showed no effect compared to a placebo. However, the FDA elected to ignore the recommendations of an outside advisory panel, and approved the medication under an accelerated approval process. The drugmaker will be required to conduct additional testing on the treatment while it is on the market, and the FDA has the option to rescind approval if a Phase 4 trial fails to show efficacy.

Biogen will sell the treatment under the trade name Aduhelm, at a list price of around $56,000 per year—not including the extensive office visits, tests, brain scans, and monitoring that will go along with the course of treatment. Pam Belluck, a writer covering science and medicine for the New York Times, joins host John Dankosky to explain the decision, and how the drug might fit into the larger picture of Alzheimer’s research.