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

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...