FDA Extends Review Of Blood Thinner Brilinta
From Associated Press (September 15, 2010)
Federal regulators need an additional three months to complete a review of an experimental blood thinner made by AstraZeneca, the company said Wednesday.
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 British company said.
The drug candidate also is being reviewed in the European Union, Canada and Brazil, among other locations.
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.
Shares of AstraZeneca PLC fell 60 cents, or 1.1 percent, to $51.88.
Posted: September 2010