Acusphere, Inc announced that the Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using Acusphere's Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension is not sufficient to justify the risks associated with the product. The vote was sixteen against, one in favour and one abstention. The committee also discussed concerns that they would like addressed to support approval of the product for the detection of coronary artery disease.
"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," said Sherri C Oberg, president and CEO, Acusphere. "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."
The Advisory Committee's recommendations, while not binding, will be considered by the FDA in its review of the New Drug Application (NDA) of Imagify. The expected FDA target action date for Imagify under the Prescription Drug User Fee Act (PDUFA) is February 28, 2009.
Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension, is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.
Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology.