How an Unproven Alzheimerâs Drug Got Approved
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogenâs Aduhelm, or aducanumab.
The F.D.A. conducted an internal inquiry this year after allegations were made that the agency was collaborating too closely with Biogen, maker of the Alzheimerâs drug Aduhelm.Credit...Andrew Kelly/Reuters
Published July 19, 2021Updated July 20, 2021, 9:29 a.m. ET
Two months before the Food and Drug Administrationâs deadline to decide whether to approve Biogenâs controversial Alzheimerâs drug, aducanumab, a council of senior agency officials resoundingly agreed that there wasnât enough evidence it worked.