Astra Zenecas Brilinta gets the USFDA nod

Astra Zeneca has announced that the US Food and Drug Administration (FDA) has approved Brilinta tablets, the company's new 60 mg dose to be used in patients with a history of heart disease. This expanded indication makes Brilinta the approved tablet 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.

According to a press release BRILINTA an oral antiplatelet treatment that works by inhibiting platelet activation is superior to clopidogrel and is the first and only oral antiplatelet to demonstrate superior reductions in cardiovascular death. The tablet also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

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 BRILINTA tablet 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).