Epix Medical submits MS-325 contrast agent to FDA
Epix Medical Inc. has taken another step on the path to the possibility of FDA clearance for its MS-325 contrast agent for vascular imaging with magnetic resonance angiography (MRA).
The company this week submitted its new drug application (NDA) to the FDA for MS-325, which is co-developed by Epix and Schering AG. Epix is the first company to seek marketing approval in any country for a new class of imaging agents designed to expand the clinical use of MRI.
MS-325 NDA has been under development for eight years. During that time, Epix has conducted 18 clinical trials, involving 1,438 subjects who received MS-325.
Epix President and CEO Michael D. Webb said MS-325-enhanced-MRA "will provide a valuable alternative to x-ray angiography. In addition, there are a significant number of people with vascular disease who, for medical or other reasons, are unlikely to undergo an x-ray angiogram, and who might benefit from a minimally-invasive MRA exam using MS-325."
The company this week submitted its new drug application (NDA) to the FDA for MS-325, which is co-developed by Epix and Schering AG. Epix is the first company to seek marketing approval in any country for a new class of imaging agents designed to expand the clinical use of MRI.
MS-325 NDA has been under development for eight years. During that time, Epix has conducted 18 clinical trials, involving 1,438 subjects who received MS-325.
Epix President and CEO Michael D. Webb said MS-325-enhanced-MRA "will provide a valuable alternative to x-ray angiography. In addition, there are a significant number of people with vascular disease who, for medical or other reasons, are unlikely to undergo an x-ray angiogram, and who might benefit from a minimally-invasive MRA exam using MS-325."