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How the FDA became too friendly with a producer of Alzheimer’s medications

Alzheimer’s disease afflicts more than 6 million Americans, and the loss of cognitive ability is devastating. Aduhelm targets amyloid-beta plaque buildup in the brain, which is linked to Alzheimer’s disease. Biogen began two clinical trials in 2015 but discontinued them in 2019 when it seemed they would not meet their goals. Internal FDA review found Biogen’s Aduhelm case “exceeded the norm in some respects”. Biogen had a “high-touch engagement strategy with regulators,” internal documents show. FDA did not consult any external advisory body or internal expert group before moving fast on this drug.