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Canada OK for AZ's Brilinta, focus turns to USA

World News | June 02, 2011


Kevin Grogan

Canada OK for AZ's Brilinta, focus turns to USA

AstraZeneca has chalked up another approval for its anti-clotting agent Brilinta, this time in Canada.

The Anglo-Swedish drugmaker noted that Health Canada has given the green light to Brilinta (ticagrelor) for the secondary prevention of atherothrombotic events in patients with acute coronary syndromes. This means the tablet is now approved in 33 countries, including the European Union (under the trade name Brilique).

AstraZeneca made a point of stressing that the Canadian approval is "an independent regulatory authorisation and has no bearing on the ongoing reviews of Brilinta in other markets. The most important of those is of course the USA and the pathway to approval there has been less than smooth.

In December, the US Food and Drug Administration issued a complete response letter and requested additional analyses of data from the 18,000-patient PLATO study. The agency expressed concern about the difference in treatment effect observed in the US and non-US patient subsets.

AstraZeneca responded, saying that difference "is most likely a reflection of an underlying interaction between ticagrelor and higher doses of aspirin". The FDA is due to make a decision on Brilinta by July 20 and analysts believe the green light will be given, although it may come with label restrictions or a requirement for a further clinical study, post-approval.

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