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New life-saving heart drug , BRILINTA, approved

Media Release

Auckland: 23 August 2011

New life-saving heart drug , BRILINTA, approved for use in New Zealand

Brilinta (ticagrelor), a new and important treatment advance for patients with acute coronary syndrome, has been approved by Medsafe for use in New Zealand.

BRILINTA is an oral antiplatelet treatment for acute coronary syndrome (ACS) in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (severe chest pain at rest that threatens a heart attack) to heart attack. ACS is estimated to affect over 20,000 New Zealanders a year.1

BRILINTA works by preventing the formation of new blood clots and maintaining blood flow in the body to help reduce a patient’s risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death.

The approval of BRILINTA in New Zealand is supported by data from the landmark PLATO (A Study of PLATelet Inhibition and Patient Outcomes) study which established the superiority of ticagrelor with aspirin over clopidogrel with aspirin for the prevention of another cardiovascular event in hospitalised ACS patients. [1] Clopidogrel is the generic medicine currently used in New Zealand to treat these conditions.

BRILINTA is the first and only oral antiplatelet to demonstrate a reduction in CV death in patients with ACS, compared to clopidogrel.

The PLATO study identified that cardiovascular mortality was significantly reduced when Brilinta was used in combination with low dose aspirin, compared to existing standard treatment with clopidogrel.[2]

Like all medicines, BRILINTA can cause side effects, although not every patient will experience them. The most common adverse events reported by patients on BRILINTA include an increase in minor bleeding (such as nosebleeds and shortness of breath). As with all oral antiplatelet medications, the use of BRILINTA can increase the risk of bleeding. In PLATO, there was no difference in overall major bleeding or in fatal/life-threatening bleeding between patients treated with BRILINTA and aspirin compared to those treated with clopidogrel and aspirin. However, non-CABG major and non-procedural major bleeding was more common.

AstraZeneca New Zealand Company President, Lance Gravatt, has welcomed Medsafe’s priority registration announced yesterday, which follows hot on the heels of US FDA approval last month.[3] With the approval in New Zealand, he says BRILINTA is now approved for use in more than 40 other countries, including the US, Brazil, Australia and Canada under the trade name BRILINTA and in the European Union under the trade name BRILIQUE.

AstraZeneca will be applying to PHARMAC to have BRILINTA listed on the pharmaceutical schedule.

[1] Wallentin L et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes (PLATO). New England Journal Medicine 2009; 361 (11): 1045-1057

[2] ibid

[3] July 2011

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