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Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?

 
• By Brenda Sandburg

A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.

Two men change their common route taking different ways
FDA has previously parted ways with an advisory committee in approving a drug • Source: Shutterstock

The US Food and Drug Administration seemed ready to approve Biogen, Inc.’s Alzheimer’s disease drug aducanumab before an advisory committee voted that the sole positive Phase III study did not support the drug’s effectiveness. The question now is whether the agency will go through with approval or require Biogen to conduct an additional trial. A look back at other instances in which the FDA approved a drug against a panel’s recommendation shows aducanumab’s unique circumstances, which may deter the agency from pushing forward with approval.

Members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee sharply criticized the agency for its analysis of aducanumab data, with one member saying the FDA's presentation during the...

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