A big win for AZ as FDA clears Brilinta for long-term use
- AstraZeneca's Brilinta (ticagrelor) was approved in 2011 for secondary prevention of acute coronary syndrome (ACS) events for up to one year. Now, the FDA has expanded the drug's label for use beyond just one year.
- The expanded indication is based on a large phase III study—PEGASUS-TIMI 54.
- In clinical studies, adding Brilinta to daily aspirin sigificantly reduced the risk of cardiovascular (CVD) deaths, stroke, or heart attack in patients who had already experienced an ACS-related event.
All told, Brilinta is a well-studied antiplatelet treatment. Almost 40,000 patients have been studied, and the medication is approved for use in more than 100 countries.
In addition, use of Brilinta is now part of the guidelines for treating ACS from the American Heart Association/College of Cardiology, as well as 11 other major consensus guidelines.
Secondary prevention of CVD events in at-risk patients represents a major opportunity to improve CVD outcomes in the overall population, while also decreasing the long-term cost of care.
AstraZeneca CEO Pascal Soriot has singled out Brilinta as an opportunity for sales growth, pointing to the Pegasus study. In fact, the company's sales department has been prepping for an all-out marketing bonanza in the wake of the label expansion.