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Aducanumab Approval Decision Delayed: Could This Be Good News?

Amendment Triggered Three-Month Review Extension

 
• By Mandy Jackson

Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.  

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The 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 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 to

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