Written by Administrator| 14 January, 2005 20:04 GMT
The Food and Drug Administration (FDA) is calling for further study prior to approval of MS-325 (gadofosveset trisodium), a new drug anticipated to be the first in a new class of blood pool contrast agents for magnetic resonance angiography (MRA) to diagnose vascular disease. EPIX shares fell sharply on news of the delay, according to press reports.The FDA has completed its review of the new drug application for MS-325 and found it to be approvable, according to its developers, EPIX Pharmaceuticals, Inc. (Nasdaq: EPIX) and Schering AG, Germany (FSE: SCH, NYSE: SHR).
'Significant Regulatory Milestone'
However, in the approvable letter, the U.S. agency requested additional clinical studies relating to the non-contrast MRA comparator scans used in the Phase III trials and to the statistical treatment of uninterpretable images. The letter identified no safety or manufacturing deficiencies according to EPIX.
EPIX says it is continuing an active dialogue with the FDA in order to determine the next steps the it will need to take to secure approval of the contrast imaging agent.
"The FDA's approvable letter is a significant regulatory milestone, although we are disappointed that the Agency has requested additional work. We and our partner Schering AG look forward to working with the FDA to define the next steps in the approval process for MS-325," says Michael D. Webb, Chief Executive Officer of EPIX.
Non-Invasive Diagnostic Potential
"We believe that MS-325 has the potential to be an important advancement for the medical community in the non-invasive diagnosis of vascular disease. We look forward to working closely with EPIX to address the agency's requests," added H. Michael Rook, Head of Diagnostic Imaging, Schering AG.
MS-325 was co-developed under a strategic partnership with EPIX, and Schering has the global marketing rights for the product. Schering has also submitted MS-325 for approval in Europe.
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