US FDA mulling new strategies for OK'ing early-stage Alzheimer's meds
This article was originally published in Scrip
Executive Summary
Recognizing that Alzheimer's drug development has increasingly been shifting to the earlier stages of the disease – before the onset of noticeable dementia – US regulators are taking steps to help industry meet the most difficult challenges of assessing functional impairment, suggesting this week it might be feasible for the agency to approve new medicines through the FDA's accelerated approval pathway on the basis of evaluating cognitive outcome alone.