AstraZeneca has filed its investigational oral antiplatelet therapy Brilinta, which is being touted by some analysts as a potential blockbuster, with regulators in the USA.

The Anglo-Swedish drugmaker has submitted a New Drug Application for Brilinta (ticagrelor) to the US Food and Drug Administration for the reduction of major adverse cardiac events in patients with acute coronary syndrome. The filing is based on the results of “a comprehensive programme”, including data from the 18,624-patient PLATO study, the Phase III head-to-head trial comparing Brilinta plus aspirin with Sanofi-Aventis/Bristol-Myers Squibb’s big-selling bloodthinner Plavix (clopidogrel), also with aspirin.

AstraZeneca has published a lot of data from the PLATO study over the past few months, and earlier this week presented findings at the American Heart Association meeting in Orlando showing that ticagrelor can reduce the risk of cardiovascular events in acutely ill heart-attack patients compared with Plavix, the current standard treatment. Moreover, Brilinta achieved this without any increase in major bleeding episodes.

Brilinta is the first in a new class of drugs, the CPTPs (cyclo-pentyl-triazolo-pyrimidines) and is chemically distinct from the thienopyridines, such as Plavix and Eli Lilly/Daiichi Sankyo’s recently-launched Effient (prasugrel). The treatment, which is the first reversibly-binding oral P2Y12 adenosine diphosphate receptor antagonist. was filed with regulators in Europe in October.