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WILMINGTON, Del. — AstraZeneca has received approval from the Food and Drug Administration for BRILINTA tablets, which help treat acute coronary syndrome (ACS).
The pharmaceutical company said late Wednesday that BRILINTA (ticagrelor), an oral antiplatelet medicine, is designed to reduce the rate of heart attack and cardiovascular death in adult ACS patients, compared to clopidogrel.
More than 1 million Americans are hospitalized with ACS every year, according to American Heart Association data cited by AstraZeneca, and it’s estimated that up to one in three patients could have a recurrent heart attack or die within one year of their first cardiovascular event.
"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 ACS patients around the world have access to this innovative medicine," David Brennan, chief executive officer of AstraZeneca, said in a statement. "With over 1 million people affected by ACS in the U.S. 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."
AstraZeneca said it will begin the process of working with hospital formularies, protocol committees, government and managed care reimbursement bodies to bring BRILINTA to patients. The prescription medication is now approved in 39 countries, including the U.S., Brazil, Australia, and Canada under the name BRILINTA and in the European Union under the name BRILIQUE.
