Acorda's Risks With Fampridine Development Look Likely To Pay Off
Executive Summary
Acorda took a risk developing a multiple sclerosis drug with a novel indication - improvement in walking ability - that had never before been studied, but it has passed a major hurdle in the form of an advisory committee review, where the clinical community got a chance to weigh in on the effort
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The Long Road To Approval: Acorda Experience With Ampyra Shows Success Of Novel Analysis Plan
Acorda Therapeutics' challenges in seeking approval for its oral therapy Ampyra to improve walking ability in patients with multiple sclerosis were greater than most from the start: it was a novel drug for a first-of-its-kind claim – and the drug yielded variable efficacy on an unproven endpoint. What seems to have made the difference is the creative analysis plan that Acorda came up with.
The Long Road To Approval: Acorda Experience With Ampyra Shows Success Of Novel Analysis Plan
Acorda Therapeutics' challenges in seeking approval for its oral therapy Ampyra to improve walking ability in patients with multiple sclerosis were greater than most from the start: it was a novel drug for a first-of-its-kind claim – and the drug yielded variable efficacy on an unproven endpoint. What seems to have made the difference is the creative analysis plan that Acorda came up with.
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.