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Cardiology: After Delays, FDA Approves Antiplatelet

by Robert Fay

The U.S. Food and Drug Administration has approved the oral antiplatelet drug ticagrelor (Brilinta) for marketing in the United States after the agency twice postponed the decision. Ticagrelor is intended to reduce thrombotic events in patients with acute coronary syndrome (ACS), including unstable angina and myocardial infarction (MI).

In clinical trials, ticagrelor with aspirin at maintenance doses between 75 and 100 mg per day proved more effective than clopidogrel (Plavix) in preventing MI and death. However, the drug's label will include a boxed warning that the effectiveness decreases when it is used with aspirin doses greater than 100 mg per day. The boxed warning will also state that ticagrelor “increases the rate of bleeding and can cause significant, sometimes fatal, bleeding.”

Ticagrelor was approved with a risk evaluation and mitigation strategy to help reduce risks. As part of the plan, the drug’s maker, AstraZeneca, must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. In addition, a medication guide will accompany all ticagrelor prescriptions providing patients with the most important information about the medication.

Source: U.S. Food and Drug Administration. 2011. FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes. Published on July 20, 2011 on the FDA website.