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US FDA panel review set for Acusphere's imaging agent

This article was originally published in Scrip

Executive Summary

The US FDA's cardiovascular and renal drugs advisory panel will meet on December 10th to discuss Acusphere's cardiovascular ultrasound imaging agent Imagify (perflubutane polymer microspheres). The proposed use is for patients with stable chest pain being evaluated for inducible ischaemia for the detection of coronary artery disease based on assessment of myocardial perfusion and wall motion. Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart and the first to demonstrate, in large clinical trials, clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion, Acusphere said. The company said its lead product candidate would present a lower cost, speedier and non-radioactive option to nuclear stress testing .The NDA is undergoing a standard review, and the user fee date is February 28th.

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