Behind The Approval Letter: A Year Of Drug Review Profiles
This article was originally published in Pharmaceutical Approvals Monthly
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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.
There are many factors that contributed to Acorda's success in gaining approval for Ampyra (dalfampridine), but looking back at the process, CEO Ron Cohen and Chief Scientific Officer Andy Blight agree that the biggest asset was having a Special Protocol Assessment for the Phase III trials.
The story of HRA Pharma’s emergency contraceptive Ella (ulipristal) bears many of the hallmarks of what many sponsors would consider a desirable regulatory path, culminating in a first-cycle approval with clean labeling.