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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.

Biogen said it provided information that the FDA requested as part of its review of the biologic license application, which the agency determined to be a major amendment

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