Thursday, July 21, 2011

Black Box Brilinta

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The blood drug Brilinta had also been under tough scrutiny by the F.D.A., analysts said, because test results in an industry-sponsored clinical trial were far worse among patients in the United States than those from the rest of the world for reasons that remain unclear.

In December, the F.D.A. rejected Brilinta in a surprising move, opposing the views of a scientific advisory panel that had voted 7-1 in favor of the drug in July 2010. The F.D.A. asked for and received more information from AstraZeneca.

In a note to investors, Timothy Anderson, analyst for Bernstein Research, said he continued to believe commercial prospects would be limited because of the pending lower prices for Plavix. The aspirin warning may be significant, he said. “It may give physicians one more reason not to use Brilinta but to stick to gold-standard Plavix.”

Posted via email from Jack's posterous

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