Aducanumab Approval Decision Delayed: Could This Be Good News?

Amendment Triggered Three-Month Review Extension

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.

LED Display - Airport flight status board — 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.

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