Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says
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.’
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US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.
Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.
Richard Pazdur is eager for a conversation about how to improve the Accelerated Approval pathway. The OCE director welcomes aducanumab’s approval – both on its own terms but also as an opportunity to broaden the discussion.