The fate of aducanumab now rests in the hands of regulators at the U.S. Food and Drug Administration (FDA). Biogen of Cambridge, Massachusetts, and Eisai Co. Ltd., Tokyo, announced on August 7 that the agency had accepted its Biologics License Application for the drug as a treatment for Alzheimer’s disease. The FDA opted to grant the application priority review, cutting the time allotted to review the application from the usual 10 months down to six. The agency is slated to wrap up its review on or before March 7, 2021. If approved, aducanumab will be the first biologic treatment that removes the hallmark amyloid plaques thought to cause the disease process.
The FDA’s formal acceptance of the application comes a month after Biogen and Eisai submitted it for priority review (Jul 2020 news).
The road to aducanumab’s arrival at the FDA’s doorstep has been fraught with both elation and controversy. The drug’s amyloid-clearing prowess captivated the field from the beginning, but halted trials, analytical about-faces, and ambitious interpretations of complex trial data have muddled the question of whether the data demonstrate a cognitive benefit (Dec 2019 news). The FDA now faces the task of deciding whether the cognitive gains observed in some trial participants warrant granting marketing approval for the drug.—Jessica Shugart
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