The US Food and Drug Administration has extended the review period for AstraZeneca's investigational anti-platelet drug Brilinta by three months - PMLiVE" /> The US Food and Drug Administration has extended the review period for AstraZeneca's investigational anti-platelet drug Brilinta by three months - PMLiVE" />

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AZ blood thinner approval delayed

The US Food and Drug Administration has extended the review period for AstraZeneca's investigational anti-platelet drug Brilinta by three months

The US Food and Drug Administration (FDA) has extended the review period for AstraZeneca's (AZ) anti-platelet drug Brilinta (ticagrelor), which is also registered as Brilique and is designed to prevent blood clots that can cause heart attacks and strokes. 

A New Drug Application (NDA) for Brilinta for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS) was submitted to the FDA for approval in November 2009.

The submission was based in part on results from the phase III PLATO trial, published in August 2009. The study demonstrated that Brilinta was generally more effective in the prevention of cardiovascular events in patients with ACS than the blockbuster Plavix (clopidogrel, Bristol-Myers Squibb and sanofi-aventis), the world's second best-selling drug. However, US patients were more likely to experience heart problems with Brilinta. 

Brilinta's review period, which was due to end on September 16, has now been extended by three months to December 16. Specific reasons for the delay have not been announced, but it may be related to the volume of trial data submitted or to concerns over labelling. However, in July the FDA's advisory committee voted 7-1 in favour of approval. 

Brilinta, which is also under review in the EU and other territories, is an important pipeline drug for AZ. According to analysts' opinions collated by Thomson Reuters, Brilinta had been predicted to achieve sales of $1.2bn by 2014. In light of the delay announcement, AZ's shares fell almost 1.5 per cent.

16th September 2010

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