By Susan Heavey
SILVER SPRING, Md., Dec 10 (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.
But FDA officials said safety issues were a top worry, and that Imagify would likely qualify for the same cautions that its competitors carry.
'There are some class effects here,' said Dwaine Rieves, head of the FDA's imaging products division.
Acusphere said the side effects were manageable and using its contrast agent with cardiac ultrasounds gave doctors necessary information while avoiding radiation from alternative tests at a lower cost.
Panel members were not convinced, saying the company's clinical trial data was not strong enough to show it would clearly offer doctors any advantages over other available tests.
'It was not persuasive largely because of inconsistency,' said panelist Ruth Day, who directs Duke University's Medical Cognition Laboratory.
They also cited safety concerns, although FDA staff told the panel it was difficult to tell whether the agent or the underlying heart problems caused patient complications.
Company studies of Imagify found that some patients who were given the agent experienced dangerously low blood pressure and lack of oxygen in the blood. Some experienced heart attacks, chest pain, flushing and other side effects.
The panel recommended that the company conduct additional larger studies that included a broader range of patients.
Shares of Acusphere were halted ahead of the panel's meeting.
(Reporting by Susan Heavey) Keywords: ACUSPHERE/ (sheavey@thomsonreuters.com; +1 202-354-5848) COPYRIGHT Copyright Thomson Reuters 2008. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
SILVER SPRING, Md., Dec 10 (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.
But FDA officials said safety issues were a top worry, and that Imagify would likely qualify for the same cautions that its competitors carry.
'There are some class effects here,' said Dwaine Rieves, head of the FDA's imaging products division.
Acusphere said the side effects were manageable and using its contrast agent with cardiac ultrasounds gave doctors necessary information while avoiding radiation from alternative tests at a lower cost.
Panel members were not convinced, saying the company's clinical trial data was not strong enough to show it would clearly offer doctors any advantages over other available tests.
'It was not persuasive largely because of inconsistency,' said panelist Ruth Day, who directs Duke University's Medical Cognition Laboratory.
They also cited safety concerns, although FDA staff told the panel it was difficult to tell whether the agent or the underlying heart problems caused patient complications.
Company studies of Imagify found that some patients who were given the agent experienced dangerously low blood pressure and lack of oxygen in the blood. Some experienced heart attacks, chest pain, flushing and other side effects.
The panel recommended that the company conduct additional larger studies that included a broader range of patients.
Shares of Acusphere were halted ahead of the panel's meeting.
(Reporting by Susan Heavey) Keywords: ACUSPHERE/ (sheavey@thomsonreuters.com; +1 202-354-5848) COPYRIGHT Copyright Thomson Reuters 2008. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.