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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.

Speaking during an interview with the Pink Sheet just ahead of the release of the first phase of review documents for aducanumab, Cavazzoni said “we really wanted to make sure that we brought to bear all of the expertise that we could to the discussion

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