An advisory committee of the U.S. Food and Drug Administration has rejected the regulatory application of the Imagify ultrasound contrast agent, manufactured by Acusphere Inc., Watertown, Mass.
The federal agency is not required to follow the committee’s recommendations; however the panel’s advice will be considered during review of Imagify’s New Drug Application.
Voting 16-1, with one abstention, the FDA’s Cardiovascular and Renal Drugs Advisory Committee advised that the agent’s diagnostic benefit was not sufficient to justify the associated risks, which include abnormally low blood pressure and fainting spells. The body also discussed issues that need to be addressed before supporting approval of the product for the detection of coronary artery disease.
The FDA had previously voiced concerns about the agent’s safety after assessing results from clinical trials.
A decision on the drug’s approval is expected by Feb. 28, 2009. Acusphere said it will work with the FDA to determine what additional information might be required for approval.
Last year, the FDA required black box warnings for GE Healthcare’s Optison and Lantheus Medical Imaging’s Definity, the two ultrasound contrast products on the U.S. market.
