FDA approves controversial Alzheimer’s drug despite uncertainty over effectivenessBMJ 2021; 373 doi: https://doi.org/10.1136/bmj.n1462 (Published 08 June 2021) Cite this as: BMJ 2021;373:n1462
- Elisabeth Mahase
- The BMJ
The US Food and Drug Administration (FDA) has approved aducanumab (Aduhelm)—a drug which aims to delay clinical decline in patients with Alzheimer’s disease—despite concerns over a lack of evidence.1
The treatment—which costs $56 000 (£40 000; €46 000) per year per patient—was approved through the accelerated approval pathway. This is used when there are uncertainties over the drug’s efficacy but it’s believed it could provide “meaningful therapeutic benefit over existing treatments” for serious or life threatening illnesses. As part of this approval, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to “verify the anticipated clinical benefit.” If these trials do not verify the anticipated benefit, the FDA can remove the drug from the market. The FDA did not specify which patients are eligible for treatment with aducanumab.
Aducanumab has been tested in two phase …