New Ultrasound Agent for CAD Submitted to FDA
April 30, 2008 - Acusphere has submitted a New Drug Application (NDA) to the FDA for approval to market Imagify (Perflubutane Polymer Microspheres for Injectable Suspension), an ultrasound imaging agent for the detection of coronary artery disease, which could prove as accurate as nuclear stress testing.
The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).
Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The Company believes it is also the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Currently, perfusion information is not available using cardiac ultrasound, but must be obtained using a nuclear stress test, an expensive and time-consuming test that involves injecting the patient with a radioactive imaging agent.
The FDA has 60 days after receipt of the NDA to review and determine if the application is sufficiently complete to permit a substantive review and meets the threshold for filing.
For more information: www.acusphere.com