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Aducanumab Approval Decision Delayed: What’s In The Major Amendment?

 
• By Mandy Jackson

From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.

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The US FDA requested more information on aducanumab and then delayed its approval decision until 7 June • Source: Shutterstock

Biogen, Inc./Eisai Co., Ltd.’s 29 January announcement that the US Food and Drug Administration’s review of aducanumab for the treatment of Alzheimer’s disease has been extended by three months, with a decision now expected on 7 June, continued the ongoing debate over the amyloid-clearing antibody’s approvability and raised new questions about what data the agency might require to make its decision.

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