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J&J seeks US approval for Xarelto in ACS patients

Positive phase III data backs third US indication for anticoagulant with blockbuster ambitions

Johnson & Johnson (J&J) has submitted its oral anticoagulant Xarelto (rivaroxaban) to the US Food and Drug Administration (FDA) for use in a further indication.

The US company is requesting the agency approve the drug to reduce the risk of (thrombotic) cardiovascular events in patients with acute coronary syndrome (ACS), a complication of coronary heart disease.

Xarelto, which J&J is co-developing with Bayer, was recently approved in the US for stroke prevention in patients with non-valvular atrial fibrillation (AF).

It can also be marketed for use in the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

In Europe, Xarelto is approved for the same uses as it is in the US, as well as for use in patients with deep vein thrombosis (DVT) and prevent recurrent DVT and pulmonary embolism (PE) following acute DVT in adults.

The latest filing for approval is based on data from the phase III ATLAS ACS 2 TIMI 51 trial, published in the New England Journal of Medicine.

The trial, which involved 15,526 patients with a recent acute coronary syndrome, saw twice-daily doses of either 2.5mg or 5mg of Xarelto compared to placebo.

Xarelto was found to reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke.

Adverse events from the drug included an increase in the risk of major bleeding and intracranial haemorrhage, although the risk of fatal bleeding was not increased.

Bayer and J&J have high hopes for Xarelto, with Bayer naming it as one of four potential blockbusters in its portfolio.

The German company said it expects the drug to reach €2bn in sales at peak following its recent series of approvals.

4th January 2012

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