MRI contrast developer Epix Pharmaceuticals has filed a response to the approvable letter it received in January from the Food and Drug Administration for its MS-325 MR blood-pool contrast agent.
In its approvable letter to Epix, the FDA had stated that its principal questions related to the noncontrast MRA comparator scans used in the MS-325 clinical trials, and to the statistical treatment of uninterpretable images. The FDA had also requested additional clinical studies to demonstrate efficacy prior to approval.
In its response, Epix said it has provided new analyses of these issues, including the manner in which the noncontrast comparator scans were performed in the phase III trials. The Cambridge, MA-based firm said that it believes these new analyses provide additional support for the conclusion that the agent is effective. Epix did not include efficacy data from new clinical trials.
By AuntMinnie.com staff writers
May 23, 2005
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