FDA conditionally approves controversial Alzheimer’s drug despite uncertainty over effectiveness

Abstract

The treatment—which costs $56 000 (£40 000; €46 000) per year per patient—wasapproved through the accelerated approval pathway. This is used when there are uncertainties over the drug’s efficacy but it’s believed it couldprovide “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.