The U.S. Food and drug Administration (FDA) has finally approved AstraZeneca's Brilinta blood thinner for patients with acute coronary syndrome - conditions, such as heart attack and angina.
Other approved drugs for these conditions are Plavix and Effient. But Brilinta, also known by its generic name ticagrelor wears off faster than these. This means that if patients need heart surgery, they can get it sooner if they're on Brilinta than if they are on Plavix or Effient.
Norman Stockbridge, the FDA's director of the cardiovascular and renal products said, “In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily.” However Brilinta has to be taken twice a day. Because the drug wears off quickly, missing a dose could be dangerous. It is also less effective if patients take more than 100 milligrams a day of aspirin. A so-called “baby aspirin” contains 85 milligrams of aspirin.
The FDA's approval of Brilinta requires AstraZeneca to institute a Risk Evaluation and Mitigation Strategy (REMS) that will alert doctors to the risk of using higher doses of aspirin along with the drug. This risk will be highlighted in a “black box” warning on the product label.
The warning will note that, like Plavix and other blood thinners, Brilinta increases the rate of bleeding and can sometimes cause fatal bleeds. In addition to bleeding, the most common adverse effect of Brilinta was difficulty breathing. The company will also have to give patients a medication guide every time they refill their Brilinta prescription.
The FDA's approval reverses its December 2010 refusal to approve the drug, despite a 7-1 vote of an expert advisory committee in favor of approval.