AstraZeneca has received European Commission marketing approval for Brilique (ticagrelor) at a new 60mg dose form for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.
The approval of new 60mg dose expands current indication to include long-term treatment beyond the first year. Such treatment may be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti platelet therapy, the company stated in a release.
''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. 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,'' Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said.
Brilique is an oral antiplatelet treatment that works by inhibiting platelet activation. Brilique 90mg is already approved in the EU for the prevention of atherothrombotic events in adults with acute coronary syndrome (ACS). In the management of ACS, the recommended maintenance dose of Brilique is 90mg twice daily during the first year after an ACS event.
Now, after the first year, patients with a history of heart attack can continue to be treated with the lower dose Brilique 60mg twice daily, which should be taken with a daily maintenance dose of aspirin of 75-150mg.
Astra Zeneca said the EU approval was based on the results from the Pegasus TIMI-54 study, a large-scale outcomes trial involving more than 21,000 patients, presented at American College of Cardiology Congress (ACC) in March 2015 and simultaneously published in the New England Journal of Medicine.
The study investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of cardiovascular (CV) death, heart attack and stroke in patients who had experienced a heart attack one to three years prior to study enrollment. The study showed that Brilique significantly reduced the primary endpoint of CV death, MI or stroke compared to placebo. The rates at 3 years were 7.77 per cent in the ticagrelor 60mg arm and 9.04 per cent in the placebo arm.
This approval is applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.
Today's announcement follows the approval on 3 September 2015 of Brilinta (ticagrelor) 60mg by the US Food and Drug Administration, to be used in patients with a history of heart attack beyond the first year, the release added.