AstraZeneca said Sept. 3 that the U.S. Food and Drug Administration has approved Brilinta (ticagrelor) tablets at a new 60 mg dose to be used in patients with a history of heart attack after the first year.
"We know that patients remain at risk beyond the first year after their heart attack,” AstraZeneca Global Medicines Development Vice President and Head of Cardiovascular and Metabolic Diseases Elisabeth Bjork said. “(The) approval is an important milestone that underscores the role Brilinta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term."
With the expanded indication, Brilinta is approved to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
Brilinta is an oral antiplatelet treatment that works by inhibiting platelet activation. The FDA first approved it in July 2011 on the basis of data from the Platelet Inhibition and Patient Outcomes (PLATO) study. For at least the first 12 months following acute coronary syndrome (ACS), it is superior to clopidogrel and is the first and only oral antiplatelet to show better reductions in cardiovascular death. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
The Brilinta 60 mg tablet is expected to be available in pharmacies by the end of the month.
AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.