A new therapy for patients, which could reduce the risk of a second heart attack after already suffering one or more cardiac episodes, is one step closer to lining pharmacy shelves in Europe.
A new 60-milligram oral dose of Brilique (ticagrelor), a product of pharmaceutical company AstraZeneca, has been granted marketing authorization by the European Union (EU).
The new dose is indicated for patients who have had at least one prior heart attack and who have been treated for at least a year with a 90-milligram dose of Brilique and aspirin, or another type of dual anti-platelet medication.
Similar approval for Brilique was granted in September 2015 by the U.S. Food and Drug Administration.
"A growing body of evidence continues to show that the risk of experiencing a subsequent cardiovascular event continues beyond the first year after a patient has a heart attack," Sean Bohen, chief medical officer at AstraZeneca, said. "We are committed to finding new treatment solutions for these patients who remain at risk, and today’s approval is an important step forward in meeting this need."
Brilique inhibits platelet activation. It is already on the market in Europe as a maintenance therapy for adult patients with acute coronary syndrome (ACS). The drug was the subject of the Pegasus TIMI-54 trial, during which the effectiveness of ticagrelor tablets plus low-dose aspirin was compared to the effectiveness of a placebo plus low-dose aspirin to prevent death, heart attack and stroke in patients who had suffered heart attacks within the last three years.
The study revealed the occurrence of death due to cardiovascular episodes to be significantly lower in patients treated with ticagrelor.