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news.Acusphere has announced that the Cardiovascular and Renal Drugs Advisory Committee of the FDA advised that the diagnostic benefit of contrast enhancement using the company's Imagify for injectable suspension is not sufficient to justify the risks associated with the product.
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The vote was 16 against, one in favor and one abstention. The committee also discussed concerns that it would like addressed to support approval of the product for the detection of coronary artery disease.
The advisory committee’s recommendations, while not binding, will be considered by the FDA in its review of the new drug application of Imagify. The expected FDA target action date for Imagify under the Prescription Drug User Fee Act is February 28, 2009.
Imagify for injectable suspension is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease. It 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 said.
Sherri Oberg, president and CEO of Acusphere, said: We appreciate the support Imagify has received from a wide variety of cardiologists, who are eager for FDA to enable them to use the drug in their practices to improve accessibility, reduce costs and avoid exposure to radiation.
We continue to believe in Imagify for its intended purpose and will work with FDA through the completion of the review process to determine what additional information might be required for approval.