FDA approves Brilinta (ticagrelor)

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The US Food and Drug Administration (FDA) has approved Brilinta (ticagrelor, AstraZeneca) tablets to reduce the rate of myocardial infarction and cardiovascular death in adult patients with acute coronary syndrome.

The new oral antiplatelet medicine, is indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST-elevation myocardial infarction, or ST-elevation myocardial infarction).

 

The FDA approval is based upon data from the PLATO (Platelet inhibition and patient outcomes) study, which shows that Brillinta reduces the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel. The difference between treatments was driven by cardiovascular death and myocardial infarction with no difference in stroke. In patients treated with percutaneous coronary intervention, Brilinta reduces the rate of stent thrombosis.

Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding. In PLATO, there was no statistical difference in patients treated with Brilinta compared to patients treated with clopidogrel in total major bleeding events (11.6% vs. 11.2%), including fatal and fatal/life-threatening bleeding events. Non-CABG (coronary artery bypass graft) major + minor bleeding events (8.7% vs. 7%) were more common with Brilinta versus clopidogrel.

The most commonly observed adverse reactions associated with the use of Brilinta vs. clopidogrel were bleeding (11.6% vs.11.2%) and dyspnea (14% vs. 8%).

 

The study also shows that maintenance doses of aspirin above 100 mg reduced the effectiveness of Brilinta, and should be avoided. After any initial dose, Brilinta should be used with maintenance aspirin doses of 75-100 mg per day. As with any unplanned subset analysis, the post hoc analysis should be treated with caution.

Brillinta is now approved in 39 countries, including the USA, Brazil, Australia, and Canada under the trade name Brilinta and in the European Union under the trade name Brilique. The antiplatelet medication is currently under regulatory review in an additional 45 countries, including Russia, India and China.

About PLATO

PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, both given in combination with aspirin and other standard therapy, designed to establish whether ticagrelor could achieve a clinically meaningful reduction in cardiovascular end points in acute coronary syndrome patients, above and beyond those afforded by clopidogrel.

The study demonstrated that treatment with Brilinta led to a greater reduction in the primary end point a composite of cardiovascular death, myocardial infarction, or stroke compared to patients who received clopidogrel (9.8% vs. 11.7% at 12 months; 1.9% absolute risk reduction; 16% relative risk reduction; 95% CI, 0.77 to 0.92; P<0.001). The difference in treatments was driven by cardiovascular death and myocardial infarction with no difference in stroke. In PLATO, the absolute difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continue to diverge throughout the 12 month treatment period.

The study also demonstrated that treatment with Brilinta for 12 months was associated with a 21% relative risk reduction in cardiovascular death (4% vs. 5.1%; 1.1% ARR; P=0.001) and a 16 percent relative risk reduction in myocardial infarction compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% absolute risk reduction; P<0.005).

In a post hoc analysis of PLATO, it was determined that more than 80% of patients worldwide, including more than 40% of patients in the USA, received low maintenance doses of aspirin (100 mg or less). Results for USA and non-USA patients taking Brilinta with these low maintenance doses of aspirin were similar.

 

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