Last month's FDA panel meeting to discuss Biogen's aducanumab added to the long list of twists and turns the Alzheimer's disease (AD) candidate has experienced over the past six years, and the committee's definitive rejection will no doubt give the agency plenty to think about ahead of the PDUFA date next March.
Prior to the all-important decision, FirstWord Pharma Plus subscribers are invited to join a discussion with Dr. Joshua Grill, associate professor and director of the Institute for Memory Impairments and Neurological Disorders at the University of California Irvine, wherein we will discuss the potential real-world impact for patients, prescribers and drug developers depending on what verdict the FDA eventually renders.
The interview will take place at 2pm ET on Wednesday, December 9. Please click here to register.
Key topics that will be discussed during the call include…if approval is granted, how aducanumab will be used in the real world and how quickly adoption is likely to ramp up, what patient subgroups would be early adopters, key safety features that will need to be monitored and how these will affect use, as well as impact on drug development and clinical trials; on the flipside if approval is not granted, is there likely to be a road forward for aducanumab, how will it affect other anti-amyloid beta mAbs, impact on the flow of R&D investment in AD along with progress updates on efforts addressing tau and other AD-related targets?
Want to get in on the action?
FirstWord Pharma Plus subscribers can register for the live webcast of our interview with Dr. Grill by following this link. We will be fielding questions from the audience and, time permitting, will solicit his thoughts on as many as we can fit in the allotted window.
Alternatively, readers can submit their own questions ahead of time for consideration. Please click here to do so.
As always, FirstWord Pharma would very much like to receive your feedback and suggestions.
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