FDA panel rejects Acusphere heart imaging agent

By Susan Heavey

SILVER SPRING, Maryland (Reuters) - A U.S. Food and Drug Administration advisory panel rejected Acusphere Inc's imaging contrast agent on Wednesday, saying possible risks outweighed its potential for screening heart patients.

In a 16-1 vote, the FDA's panel of outside advisers said there was not consistent data to prove the product worked, and expressed concern about potential side effects, including low blood pressure. One panelist abstained.

"How it actually performed was disappointing in light of the risks," said panel member Tal Geva, a Harvard Medical School pediatrician.

Acusphere wants FDA approval to market Imagify, also known as AI-700, for use with cardiac ultrasound scans to screen patients with chest pain to see if they have heart disease and if they need more tests.

Cardiac ultrasounds, also known as echocardiograms, use sound waves to create images of the heart, which can be enhanced by contrast products.

FDA has been concerned about side effects with contrast imaging agents and earlier called for warnings after hundreds of reports of complications, including deaths. In June, it sought advice from an advisory panel, which called on companies to collect additional data for those already on the market.

FDA officials have said it is unclear whether Imagify's risks are worth it since it helps diagnose heart issues but does not treat them, and are seeking the panel's advice. It usually follows its panel's recommendations.

Acusphere said its product is not the same as other "microbubble" contrast agents that contain gas within a molecular shell. Imagify is a "microsphere" agent that holds gas within a porous material, it said.