As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval
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.
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3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals
Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.
Two House committees have launched investigations into the US FDA approval of Biogen/Eisai’s Aduhelm for Alzheimer’s, assuring that headlines questioning the effectiveness of the therapy will continue. It didn’t have to be this way.
Jacqueline Corrigan-Curay brings a broad array of policy experience, from trial design to real-world evidence to supply chain and post-market surveillance, to the CDER principal deputy director role, though US FDA is not yet able to articulate exactly what her promotion will entail.