AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved 'Brilinta' (ticagrelor) tablets at a new 60 mg 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, the company said in a release.
`Brilinta', an oral antiplatelet treatment that works by inhibiting platelet activation, was first approved by the FDA in July 2011 on the basis of data from the PLATO study.
Astra Zeneca claims the drug to be 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 90 mg 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 60 mg 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.''
The expanded indication for Brilinta has been approved under FDA Priority Review, a designation 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 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.
Brilinta has been approved in over 100 countries and is included in 12 major ACS treatment guidelines globally. In the American Heart Association (AHA)/American College of Cardiology (ACC) 2014 NSTE-ACS Guideline, BRILINTA is preferred over clopidogrel for the maintenance treatment in NSTE-ACS patients (Class IIa) and is recommended as a treatment option in the management of NSTE-ACS patients (Class I), AstraZeneca said.
The new BRILINTA 60mg tablet is expected to be available in pharmacies by the end of September 2015, it added.