FDA Extends Review of AstraZeneca Blood Thinner
September 16, 2010
The Associated Press reports, federal regulators need an additional three months to complete a review of an experimental blood thinner made by AstraZeneca, the company said. In July, FDA advisory committee members voted 7 to 1 to recommend the approval of Brilinta in
patients with acute coronary syndrome, or blocked arteries. The committee''s advice is not binding, but the FDA usually follows it. The U.S. Food and Drug Administration review that was scheduled to be completed Thursday was pushed back to Dec. 16, the company said. An international study conducted by AstraZeneca showed that patients taking Brilinta versus Plavix were less likely to experience various heart-related problems. But U.S. patients studied were more likely to report heart problems while taking Brilinta. The blood thinner market is currently dominated by Plavix, a Sanofi-Aventis SA and Bristol-Myers Squibb Co. product that brought in $9.1 billion in global sales last year.