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news.Acusphere has announced that the new drug application for approval to market its lead product candidate, Imagify, has been accepted for review by the FDA.
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Acusphere’s Imagify is an ultrasound imaging agent for the detection of coronary artery disease. The new drug application (NDA) includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multicenter Phase III clinical trials, Ramp-1 and Ramp-2, the company said.
Imagify is claimed to be the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The company also believes that it is 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.
The FDA acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing. With a standard review, under the FDA Prescription Drug User Fee Act, the target action date is 10 months from the submission date, or February 28, 2009.