Alzheimer’s Can Follow HIV And Become Chronic Condition If Science Advances, Woodcock Argues
The acting US FDA commissioner equates drug development in the neurodegenerative diseases to work on HIV.
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Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.
Biogen/Eisai’s newly-approved Alzheimer’s drug could be headed to CMS’ Medicare advisory committee, which is chaired by vocal drug pricing reform advocate Peter Bach.
Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.