Acusphere Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres for Injectable Suspension).
Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. 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. More than 10 million stress imaging procedures are done each year in the U.S. to detect coronary artery disease.
Sherri C. Oberg, Acusphere’s President and Chief Executive Officer, said, “We are delighted to have reached this critical milestone in the development of Imagify. We believe Imagify offers important benefits in the detection of heart disease, including lower costs, speedier results and greater accessibility without exposure to radiation, and we are eager to bring those benefits to millions of patients and clinicians in the U.S.”
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.