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Xarelto prospects boosted by data in acute coronary syndrome

Trial showed Bayer and Johnson & Johnson's antithrombotic drug cut heart attacks, strokes and cardiovascular deaths

Bayer and Johnson & Johnson's antithrombotic drug Xarelto cut heart attacks, strokes and cardiovascular deaths in a trial involving more than 15,000 patients with acute coronary syndromes (ACS), potentially opening up a major new market for the drug.

The data, presented at the American Heart Association annual meeting in Orlando yesterday, showed that Xarelto (rivaroxaban), given on top of aspirin and Sanofi and Bristol-Myers Squibb's Plavix (clopidogrel), reduced the combined endpoint by 16 per cent when compared to placebo, although there was a trade-off in terms of an increased risk of bleeding and intracranial haemorrhage.

Bayer and J&J's drug also achieved reductions in overall and cardiovascular mortality versus placebo. While there was a threefold increase in bleeding episodes, the rate of fatal bleeds was similar in both the Xarelto and placebo groups. Xarelto is an oral inhibitor of factor Xa.

Xarelto was tested at two doses, with the lower (2.5mg twice-daily) representing the best option in terms of risk-benefit, according to the investigators in the study, called ATLAS ACS 2 TIMI 51. The results have also been published in the New England Journal of Medicine (November 13, 2011).

Bayer and J&J say they intend to file for approval of Xarelto in ACS by the end of the year in both the US and Europe. If approved, the product would tap into a new market estimated as being worth up to $1 billion a year.

The results are particularly impressive because another antithrombotic in the same class as Xarelto, Bristol-Myers Squibb and Pfizer's Eliquis apixaban, had to be stopped early in 2010 because of an increased bleeding rate. Meanwhile, another factor Xa inhibitor, Astellas' darexaban, was also dropped because of bleeding complications, leading to speculation that it would not be possible to safely add antithrombotic drugs to aspirin and clopidogrel.

Xarelto seems to have walked a very fine line between efficacy and safety in the latest trial, thanks in part to a decision to exclude high-risk patient such as those who had a previous stroke or transient ischaemic attack (TIA or 'mini stroke'), and the fact that the trial did not include a very large proportion of older patients who tend to be more prone to bleeding episodes.

If approved, it would become the first agent indicated for use alongside aspirin and clopidogrel - so-called dual antiplatelet therapy - in ACS patients.

Two other drugs have been cleared recently for use in ACS, namely AstraZeneca's Brilique (ticagrelor) and Eli Lilly's Effient (prasugrel), but these are used in place of clopidogrel.

14th November 2011

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