A U.S. Food and Drug Administration (FDA) panel rejected the regulatory application for the Imagify ultrasound contrast agent from Acusphere of Watertown, MA.
In a meeting on December 10, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted by a 16-1 margin with one abstention that the risks of the product do not justify the diagnostic benefits. The committee also discussed concerns that it would like addressed to support approval of the product for detecting coronary artery disease.
The FDA said prior to the committee meeting that it had concerns about the safety of the agent based on results from clinical trials. The FDA in 2007 required black box warnings for the two ultrasound contrast products on the U.S. market: Definity from Lantheus Medical Imaging of North Billerica, MA, and Optison from GE Healthcare of Chalfont St. Giles, U.K.
The committee's vote is not binding, but it will be considered by the FDA in its review of Imagify's new drug application (NDA). The target date for FDA action on the NDA is February 28, 2009.
Acusphere said that it plans to work with the FDA to determine what additional information might be required for approval of the agent.
Related Reading
FDA 'concerned' over Acusphere agent, December 9, 2008
Bernstein leaves Acusphere, November 18, 2008
Acusphere's Imagify to get FDA review, October 13, 2008
Acusphere taps new VP, September 25, 2008
Acusphere receives Nasdaq noncompliance notice, August 14, 2008
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