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Acusphere Imagify NDA is first for company, first for ultrasound cardiac imaging

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Acusphere's April 28 NDA for Imagify (perflubutane polymer microspheres for injectable suspension), the first new drug submission for the company, seeks approval of the polymer microsphere-encapsulated gas product as an ultrasound imaging agent to assess myocardial perfusion for the detection of coronary artery disease. If approved, Imagify would be the first ultrasound myocardial perfusion imaging agent. Acusphere believes Imagify "is also the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing." The NDA includes data from studies in more than 1,000 patients, including the two pivotal international multi-center Phase III Real-Time Assessment of Myocardial Perfusion clinical trials, RAMP-1 and RAMP-2. "Imagify is designed to provide real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests," the company says. The agent is designed to work with currently available equipment and imaging techniques

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