Controversial Alzheimer’s Drug Aduhelm Dropped by Drugmaker After Doubtful Data and Denied Coverage

Aduhelm, once heralded as the first new medication to treat Alzheimer’s disease since 2003, has been discontinued by its maker, Biogen. The drug was unable to overcome key obstacles, including questionable fast-tracking approval by the U.S. Food and Drug Administration despite poor trial data and inconsistent demonstrated benefits. Mired in Controversy On January 31, Biogen announced it would cease development and ongoing clinical trials for its Alzheimer’s drug Aduhelm (aducanumab). The FDA granted Aduhelm accelerated approval in 2021, despite concerns over limited benefits and risks to patients. This decision went against the advice of the agency’s own advisory panel. Aduhelm has been controversial from the start. Clinical trials found the monoclonal antibody was intended to reduce amyloid plaque typical of Alzheimer’s disease, but showed inconsistent benefits. The ENGAGE Phase 3 trial showed no benefit over placebo....