FDA Questions New AstraZeneca Blood Thinner

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FDA Questions New AstraZeneca Blood Thinner

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Associated Press - Jul. 26, 2010

WASHINGTON -- Federal health regulators say an experimental blood thinner from AstraZeneca PLC appears effective, though study results in the U.S. did not match those seen abroad.

London-based AstraZeneca has asked the Food and Drug Administration to approve its drug Brilinta to prevent blood clots in patients at risk for heart problems. The blood thinner market is currently dominated by Sanofi-Aventis SA and Bristol-Myers Squibb Co.'s blockbuster drug Plavix.

However, FDA regulators have questions about the effectiveness of AstraZeneca's drug, according to a review posted online Monday afternoon.

An international, 18,000-patient study conducted by AstraZeneca showed that patients taking Brilinta versus Plavix were less likely to experience various heart-related problems, including heart attack and stroke. But U.S. patients in the study showed unfavorable results, with patients taking Brilinta being more likely to report heart problems.

On Wednesday the FDA will ask a panel of outside experts to weigh the results and recommend whether AstraZeneca's drug should be approved. The panel's advice is not binding, but the FDA often follows the group's guidance.

A positive decision would allow Brilinta to compete against Plavix and Eli Lilly & Co.'s Effient in the U.S. With global sales of $9.1 billion in 2009, Plavix was the world's second-best selling drug behind Pfizer Inc.'s cholesterol drug Lipitor.

Lilly's drug, which launched last summer, has faced an uphill climb with sales of $22.9 million in the last quarter.