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FDA shows caution in evaluating new heart drug, delays report

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Could the U.S. Food & Drug Administration (FDA) finally be showing caution in its evaluation of potential new medications? After being thrashed by the media and the public in recent months for its apparent inability to protect us from insufficiently tested drugs that turn out to be ineffective or, worse, downright dangerous, the FDA seems to be putting on the brakes in its consideration of a new drug offered by manufacturer Eli Lilly and Daiichi Sankyo.

On Sept. 24, Forbes.com was anticipating a decision on Lilly and Sankyo’s new blood thinner, prasugrel, which would be used to treat heart disease. Forbes reported that the FDA had decided in June after an initial review of the drug to delay its decision until Sept. 26.

However, today the FDA delayed approval of the drug for a second time. According to an Associated Press report, the agency says it still has not completed its review of the drug, which was submitted in January. The AP quotes Lilly spokesperson Jennifer Stotka as saying the evidence from prasugrel trials and studies is a “very large, complex submission,” and that she is not surprised at the FDA request for more time.

Prasugrel would be a direct competitor with Plavix, the leading drug for treatment of cardiovascular disease, manufactured by Sanofi-Aventis and Bristol-Myers Squibb.

According to a second Forbes report released today upon news of the second delay, prasugrel is designed to treat patients with acute heart conditions who are at risk of developing blood clots. The news agency says prasugrel’s manufacturers paid for a study of 14,000 patients to test the medication, which it says prevented more heart attacks than Plavix. However, the report says, the drug also caused more dangerous bleeding, with deaths as a result almost canceling out the gain in cardiovascular benefit.

Results of this study, the TRITON-TIMI 38 trial, were apparently enough cause for concern that the FDA is taking its time to weigh its decision.

Forbes says cardiologists expect the drug to ultimately gain approval, although with “significant warnings” for those at higher risk for bleeding. The report says the drug also has hopes for wide use in angioplasty procedures, where drug-coated stents are used to open a clogged artery.

For now, however, the wait is on.