Biogen has announced it will give up ownership and halt sales of Aduhelm, an embattled Alzheimer's disease drug that was scrutinized following its 2021 approval.
Biogen said it terminated a licensing agreement with Neurimmune, which controls the rights to the drug.
Aduhelm, which became the first new Food and Drug Administration-approved drug for the disease since 2003, targets amyloid beta proteins that form in the brains of Alzheimer's patients. The FDA's accelerated approval of the drug in 2021 was seen as problematic by many in the medical community because the agency overruled the advice of expert outside advisers who said clinical trials had failed to prove the drug was effective.
Two years before getting approval, Biogen halted its trials early because researchers were getting mixed results that suggested the drug did not slow Alzheimer’s progression. Together, Biogen and the FDA began reanalyzing the data and concluded the drug worked, ultimately leading to the FDA's conditional approval.
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