Acorda's Novel Primary Endpoint For Ampyra Was Made Possible By A Supporting Scaffolding Of Secondary Analyses
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Secondary analyses in the pivotal trials of Acorda’s Ampyra (dalfampridine) were of front-line interest to FDA as the agency grappled with the first indication for improving walking ability in multiple sclerosis patients and an untested primary endpoint.