The Food and Drug Administration (FDA) backed the use of Brilinta tablets to reduce the risk of heart attacks, strokes and death, AstraZeneca said in a statement.
“The FDA approval of Brilinta is good news for patients in the United States and represents a significant milestone as we seek to help ensure… patients around the world have access to this innovative medicine,” AstraZeneca chief executive David Brennan said in the statement.
AstraZeneca is hoping that the drug, which won EU approval in late 2010, can rival current blockbuster heart drug Plavix that is produced by pharmaceutical giant Sanofi-Aventis and BMS.
“With over one million people affected by ACS (acute coronary syndrome) in the US each year, the fact that physicians have a new and more effective treatment option than clopidogrel to help reduce the rate of heart attack and cardiovascular death in these patients is an important advance,” Brenna said.
According to the American Heart Association, over one million Americans are hospitalised with ACS every year.
Brilinta is now approved in 39 countries including the US, Brazil, Australia and Canada and in the EU it is marketed under the trade name Brilique.