Shelley Wood

June 01, 2011

June 1, 2011 (Ottawa, Ontario) — Health Canada has granted approval to ticagrelor for the secondary prevention of atherothrombotic events in patients with ACS, the drugmaker, AstraZeneca, has announced [1].

Canada joins the EU and a range of other countries in approving the drug, to be marketed in Canada as Brilinta. Meanwhile, in the US, the FDA has twice postponed a decision on ticagrelor since an advisory committee voted recommending approval of the agent in July 2010. In February, the company announced that the FDA has accepted its resubmission of the new drug application (NDA) and has set a new date for a decision on approval of July 20, 2011.

Support for the approval comes primarily from the 18 000-patient PLATO trial, conducted in 43 countries around the world, showing that ticagrelor plus aspirin reduced the primary end point--a composite of death from vascular causes, MI, or stroke--by 16% compared with clopidogrel plus aspirin over 12 months (9.8% of patients receiving ticagrelor suffered a primary-end-point event compared with 11.7% of those taking clopidogrel [p<0.001]).

But the outcome in the subset of 1814 patients in the US and Canada was worse in those taking ticagrelor than in those on clopidogrel, with a primary end point occurring in 11.9% of ticagrelor-treated patients compared with 9.6% of those on clopidogrel, although the difference was not significant. That so-called "North American anomaly" is believed to be the key reason why the FDA has taken its time making a decision on the drug. The company has previously said that the additional analyses of the PLATO trial requested by the FDA focused primarily on interactions between ticagrelor and aspirin, which is typically given in higher doses in the US than in Europe in ACS.

Others, however, have alleged that there were differences in how the study conduct was monitored at the different international sites.

In announcing the Health Canada decision today, the company notes that the most common adverse events reported by patients on ticagrelor include an increase in bleeding (such as nosebleeds), shortness of breath, and headache.