The FDA’s ruling brings widespread criticism and multiple investigations.
Alzheimer's Disease, which afflicts more than 6 million people in the U.S., destroys brain cells involved in memory and critical thinking. This article appeared in the January/February 2022 issue ofUnder different circumstances, the U.S. Food and Drug Administration’s approval of the medication aducanumab might have been celebrated as one of the great therapeutic advances of 2021. The drug was proclaimed as the first medication to target the underlying pathology of Alzheimer’s disease.
In one sense, the drug had done its job: clearing patients’ brains of amyloid plaques, the deposits of abnormal protein that are a hallmark of Alzheimer’s. Whether amyloid causes the disease remains a matter of debate, however — and aducanumab’s performance, like that of many previous candidate drugs, failed to settle the question. Nonetheless, Biogen wasn’t ready to surrender.
The FDA could have ended things there. Instead, the agency greenlit aducanumab last June, under a program called accelerated approval — designed to provide early access to medications that affect a disease biomarker deemed “reasonably likely to predict clinical benefit.” Biogen would be required to mount another study, with results expected by 2030. Meanwhile, it could sell its product under the trade name Aduhelm to any patient with Alzheimer’s.
Two congressional committees announced that they would investigate Aduhelm’s approval process, pricing, and labeling. Then STAT News published an exposé reporting that Biogen had waged a campaign called Project Onyx to influence the agency, and had collaborated closely with top officials to get the drug approved.
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