Keywords: AstraZeneca, Brilinta, AHA, Research, FDA filing

AstraZeneca presents strong Ph II results for Brilinta at AHA, beating Plavix; files drug with FDA

Article | 19 November 2009

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Anglo-Swedish drug major AstraZeneca announced the results of the Phase II studies, ONSET/OFFSET and RESPOND for ticagrelor (trade name Brilinta) at the annual American Heart Association Scientific Sessions in Orlando, Florida, with the first study’s results being simultaneously published in the medical journal Circulation. The company has also filed for approval of the drug in the USA.

The ONSET/OFFSET data showed that treatment with ticagrelor achieved a more rapid onset of antiplatelet effect (41% IPA versus 8% at 30 minutes; P<0.0001), greater inhibition of platelet aggregation (ipa) that was sustained during maintenance phase of treatment (ipa; p><0.0001 at all times) and faster offset ipa compared to french drug major sanofi-aventis’ plavix (clopidogrel), in patients with stable coronary artery disease (cad) on aspirin therapy.>

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Platelets initiate the formation of blood clots by sticking together (clumping or aggregating), a process called platelet aggregation. Inhibition of platelet aggregation is the prevention of clumping of platelets in the blood, which reduces the risk of clot formation and subsequent thrombotic events.

These results were achieved using ticagrelor 180mg loading dose followed by 90mg twice daily, as studied in PLATO (A Study of Platelet Inhibition and Patient Outcomes), compared to clopidogrel 600mg loading dose followed by 75mg once daily dose.

Submits NDA to FDA

Meantime, AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration for ticagrelor for the treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor of Brilinta is pending approval from the FDA, the company noted.

This submission is based on the results of a comprehensive programme, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel plus aspirin.