How To Validate A Novel Primary Endpoint: Ampyra's Lineup Of Pivotal Trial Endpoints & Analyses
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Acorda conducted two fundamentally identical Phase III trials for Ampyra (dalfampridine), studies MS-F203 and MS-F204. The trials, with a novel primary endpoint for the multiple sclerosis setting, were conducted under Special Protocol Assessments from FDA. Since the primary endpoint was untested and for an unprecedented indication (and involved a complex analysis plan), the secondary endpoints were of particular importance in providing reassurance of the drug's effect.
You may also be interested in...
Acorda's Novel Primary Endpoint For Ampyra Was Made Possible By A Supporting Scaffolding Of Secondary Analyses
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.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product