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Astellas's Blood-Thinning Drug Raises Bleeding In Mid-Stage Study
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Written by Sten Stovall   
Tuesday, 30 August 2011
   Japanese company Astellas Pharma Inc.'s (4503.TO) experimental circulatory disease pill darexaban increased bleeding by more than double in a clinical study of heart patients with acute coronary problems.

The mid-stage dose-finding study was presented at the European Society of Cardiology in Paris. Using 1,279 patients, it also showed the new blood thinner produced no decrease in rates of death, strokes or heart attacks compared with placebo.

Professor Gabriel Steg from the Hospital Bichat in Paris said the study produced no other safety concerns and added that the RUBY-1 trial was too small to evaluate efficacy of the drug for that category with any certainty.

"Establishing the role of low-dose darexaban in preventing major cardiac events after ACS [acute coronary problems] now requires a large Phase III trial, " Steg said in a statement.

The Astellas drug belongs to the same Factor Xa inhibitor class of medicines as Pfizer Inc. (PFE) and Bristol-Myers Squibb Co.'s (BMY) Eliquis, which this week impressed health professionals when tested in another group of patients-- those at risk of stroke because they have dangerously irregular heart rhythms.

Johnson & Johnson (JNJ) and Bayer AG (BAYN.XE) have another Factor Xa, Xarelto, while privately held Boehringer Ingelheim GmbH sells a new anticoagulant with a different mechanism, called Pradaxa. Xarelto's chemical name is rivaroxaban while Pradaxa is also known as dabigatran.
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