AstraZeneca has announced that the FDA has given approval for a new dosage of Brilinta (ticagrelor) of 60 mg twice daily, for patients for prevention of cardiovascular death, myocardial infarction and stroke beyond the first year after a cardiovascular event.
The drug regulator’s green light could potentially more than double the number of patients eligible for the medicine. Ticagrelor is an antiplatelet agent that was previously approved in a 90 mg twice-daily dose for use in patients up to 1 year after an acute coronary syndrom (ACS) event for prevention of cardiovascular events and stent thrombosis.
Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said a press statement:
“We know that patients remain at risk beyond the first year after their heart attack. Today’s approval provides an important new treatment option and underscores the role Brilanta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term.”
Expanded indication for Brilanta was approved under FDA Priority Review. This designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The approval is based on the PEGASUS TIMI-54 study, 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, lead investigator for PEGASUS-TIMI 54, said:
“The PEGASUS-TIMI 54 trial demonstrated that the addition of ticagrelor to low-dose aspirin in patients with a prior heart attack significantly reduced 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.”
The new Brilanta 60mg tablet is expected to be available in pharmacies by the end of September 2015.