EPIX Pharmaceuticals (EPIX) Submits Response To FDA Approvable Letter For MS-325; Conference Call And Webcast Scheduled
10/19/2005 5:09:51 PM
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 23, 2005--EPIX Pharmaceuticals, Inc. (Nasdaq: EPIX) today announced that it has submitted a response to the approvable letter received from the U.S. Food and Drug Administration (FDA) in January 2005, for MS-325. MS-325 is anticipated to be the first in a new class of MRI blood pool contrast agents, and is specifically designed for magnetic resonance angiography (MRA).
The FDA indicated in the approvable letter that its principal questions related to the non-contrast MRA comparator scans used in the MS-325 clinical trials and to the statistical treatment of uninterpretable images. In the approvable letter, the FDA requested additional clinical studies to demonstrate efficacy prior to approval.
In its response submitted to the FDA, EPIX provided new analyses of these issues, including new analyses of the manner in which the non-contrast comparator scans were performed in the Phase III trials. The company believes these new analyses provide additional support for the conclusion that MS-325 is effective. EPIX' response did not include efficacy data from new clinical trials.