FDA approves label expansion for AstraZeneca’s Brilinta

The US Food and Drug Administration (FDA) has approved AstraZeneca’s Brilinta® (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year.

With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.

Brilinta is an oral antiplatelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis of data from the PLATO study. For at least the first 12 months following ACS, it is superior to clopidogrel and is the first and only oral antiplatelet to demonstrate superior reductions in cardiovascular death. Brilinta also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. In the management of ACS, the recommended maintenance dose of Brilinta is 90mg twice daily during the first year after the ACS event. After one year, patients with a history of heart attack can now be treated with 60mg twice daily.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said, “We know that patients remain at risk beyond the first year after their heart attack. Today’s 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.”

Brilinta plus aspirin was shown to significantly reduce the risk of having another heart attack

The approval of the expanded indication is based on the PEGASUS TIMI-54 study1, a large-scale outcomes trial involving more than 21,000 patients. PEGASUS TIMI-54 investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of cardiovascular death, heart attack and stroke in patients who had experienced a heart attack one to three years prior to study enrollment.

Marc Sabatine, MD, MPH, Chairman, Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women’s Hospital, Boston, MA, USA and lead investigator for PEGASUS-TIMI 54, said, “The PEGASUS-TIMI 54 trial demonstrated that the addition of ticagrelor to low-aspirin in patients with a prior heart attack significantly reduces the risk of dying from cardiovascular causes, having another heart attack, or having a stroke. While it’s important that physicians tailor their treatment approach for each patient, these data speak to the clinically important benefit that can be gained when adding ticagrelor to the current standard therapy in a patient population at increased risk for recurrent cardiovascular events in the long-term.”