An application to use AstraZeneca’s Brilinta to treat patients with a history of heart attack has been placed on a fast track regulatory pathway in the US, meaning that approval could be granted within just six months.
The US Food and Drug Administration has assigned a priority review based on Phase III data showing that Brilinta (ticagrelor), along-side low-dose aspirin, can improve long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction. The move signals the regulator’s belief that the drug could offer a benefit over existing approaches.
Ticagrelor, a P2Y12 (P2T) antagonist, was granted approval in the E.U. in December 2010 for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS).
The product was first launched in Germany and the U.K. as Brilique(TM) in January 2011. Also in 2011, the product received approval in Canada.
Ticagrelor was recommended for approval by the FDA in July 2010; however, in December 2010, a complete response letter was assigned.
In July 2011, FDA approval was granted and U.S. launch took place in August.