A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen’s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company.
In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s. Two other panelists said it the data was “uncertain.”
The FDA could still approve the drug, which would make it the first drug approved to slow cognitive decline in people living with the disease and the first new treatment for Alzheimer’s in nearly 20 years.
