The Canadian regulatory agency, Health Canada, has approved the novel antiplatelet agent ticagrelor for the secondary prevention of thrombotic events in patients with acute coronary syndromes (ACS), the drug’s manufacturer, AstraZeneca (Wilmington, DE), announced June 1, 2011.

The action brings the total number of countries in which ticagrelor is approved to 33, while in 42 others, including the United States, it is under regulatory review.

After an advisory committee of the US Food and Drug Administration (FDA) voted in favor of approval in July 2010, the agency first postponed a decision and then in December requested additional analyses of supporting data. In February 2011, AstraZeneca announced that the FDA had accepted the company’s revised New Drug Application and set July 20, 2011, as the deadline for a decision.

Results of the multicenter randomized PLATO trial (Wallentin L, et al. N Engl J Med. 2009;361:1045-1057), which according to an AstraZeneca press release formed the basis for the Canadian approval, showed ticagrelor to be superior to clopidogrel in reducing the primary endpoint of death from vascular causes, stroke, and MI in ACS patients who also received aspirin. Although ticagrelor did not increase overall major bleeding, it was associated with a higher rate of non-CABG major bleeding.

The FDA’s hesitation regarding approval of ticagrelor reportedly stems from concern over discrepant outcomes in North American patients enrolled in PLATO. In that subgroup, patients randomized to ticagrelor had a higher incidence of the primary outcome compared with those assigned to clopidogrel, although the difference was not statistically significant.

Ticagrelor, an oral reversible, direct-acting antiplatelet agent, will be marketed in Canada as Brilinta.

2. AstraZeneca. FDA Assigns New PDUFA Date for BRILINTA (ticagrelor tablets) [press release]. http://www.astrazeneca.com/Media/Press-releases/Article/US-FDA-Assigns-new-PDUFA-date-for-BRILINTA-TICAGRELOR-TABLETS. Published February 4, 2011. Accessed June 2, 2011.

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• FDA Advisory Panel Votes to Recommend Ticagrelor Approval
• Ticagrelor Shows More Rapid, Powerful Platelet Inhibition Than Clopidogrel