Acorda Therapeutics faces a long-awaited FDA advisory panel review today of its MS drug Fampridine, and Nasdaq stopped trading in the company's shares until the experts have voted on its fate. A key question the experts face is whether they should approve a drug that appears to improve patients' ability to walk while raising the risk of seizures.
There's a lot riding on the review. Biogen Idec committed up to $510 million in its licensing pact for the drug, and proffered $110 million of that upfront. Acorda had to resubmit its NDA earlier in the year after regulators asked them to reformat the submission and add more information. FDA staffers raised new questions about the drug last week when they questioned the clinical significance of the increase in walking speed researchers had demonstrated in clinical trials.
The improvement noted for Fampridine was "numerically quite small, and the average time to complete the 25-foot walk was not different between the treatment groups in either study," said Eric Bastings, deputy director of the FDA's Division of Neurology Products, in a memo last week. And analysts fretted that the FDA may be shifting the standard for approval.
- check out Acorda's release