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Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says

 
• By Kate Rawson

Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’

The US FDA eventually determined that accelerated approval eventually fit Aduhelm 'like a glove.' • Source: Alamy

The Center for Drug Evaluation & Research cast a “very wide” net inside the agency to gather advice and input on the decision to grant accelerated approval for Biogen, Inc./Eisai Co., Ltd.’s Alzheimer’s drug Aduhelm (aducanumab-avwa), and in the end – with the exception of the biostatisticians who reviewed the data – there was general agreement that the agency was on “very solid ground” in applying the pathway, CDER Director Patrizia Cavazzoni said.

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