The drug maker Biogen said on Wednesday it would abandon its ownership rights to Aduhelm, an Alzheimer’s drug that had provoked fierce criticism of the company and regulators after it was approved based on weak evidence that it would help patients.
The company will also stop a clinical trial that the Food and Drug Administration had ordered to confirm whether the drug is effective in slowing the progression of Alzheimer’s disease.
Biogen’s decision closes out a yearslong saga that generated outrage and eroded trust in the regulatory process for bringing new medicines to market.
adviser called the approval of the drug perhaps “the worst approval decision that the F.D.A.
has made that I can remember.” A congressional inquiry later found that the F.D.A.’s process for approving Aduhelm was “rife with irregularities” and involved “lapses in protocol,” including unusually close collaboration with Biogen.
Persons:
Biogen, Aduhelm
Organizations:
and Drug Administration