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The Long Road To Approval: Acorda Experience With Ampyra Shows Success Of Novel Analysis Plan

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

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