FDA grants priority review to expand use of Brilinta

June 3, 2015

The FDA has granted Priority Review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.

FDA has granted priority review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.

Brilinta is an oral antiplatelet used for acute coronary syndromes (ACS). It acts as a P2Y12 receptor antagonist to inhibit platelet activation and reduce the rate of thrombotic cardiovascular events, such as heart attack or cardiovascular (CV) death.

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"AstraZeneca believes there is clear need for treatment options beyond the current standard of care of aspirin for the long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction; recent research has shown that 1 in 5 patients will have a further heart attack, stroke or CV death in the subsequent 3 years following a heart attack, even if patients were event free after 12 months," according to a company statement.

The acceptance of the supplemental New Drug Application is based on the results of the PEGASUS-TIMI 54 study, which included more than 21,000 patients. The study investigated ticagrelor tablets plus low-dose aspirin compared to placebo plus low-dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack 1 to 3 years prior to study enrollment.

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Study results showed that twice-daily doses of either ticagrelor 60 mg or 90 mg significantly reduced risk of CV death, myocardial infarction, or stroke compared with placebo. However, treatment with ticagrelor increased risk of major bleeding.

The most common adverse reactions associated with the use of Brilinta include an increased risk of bleeding and dyspnea. Brilinta is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding. It is also contraindicated in patients with severe hepatic impairment. Maintenance doses of aspirin greater than 100 mg have been shown to decrease effectiveness of Brilinta and should be avoided. 

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