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Bayer wins EU approval for Xarelto in ACS

Comes despite US FDA decision not to recommend extra indication for anticoagulant

Bayer Xarelto rivaoxaban

Bayer's big hopes for its next generation blood thinner Xarelto are somewhat back on track after the European Commission (EC) approved the drug's use to prevent cardiovascular events in patients who have endured an acute coronary syndrome (ACS).

The German company and its marketing partner in the US Johnson & Johnson took a hit earlier this year when the FDA issued its second Complete Response Letter to recommend against the use of Xarelto (rivaroxaban) in a similar indication, denying the two companies a major market for a drug.

The latest approval is a huge boost for Bayer though, with the company holding exclusive marketing rights in Europe, and puts the drug back on course to meet revenue expectations of $2bn by 2015.

Sales of Xarelto outside the US are already strong, topping €322m during 2012 as the drug made its mark in its current approvals, which include the prevention of venous thromboembolism; the prevention of stroke in patients with non-valvular atrial fibrillation; and the treatment and prevention of deep vein thrombosis and pulmonary embolism.

The latest approval in ACS also continues to give Xarelto an edge ahead of rival next generation anticoagulants like Pradaxa (dabigatran) from Boehringer Ingelhiem, and Eliquis (apixaban) from Pfizer/ Bristol-Myers Squibb, with both of these drugs lagging behind Bayer's blood thinner in the number of approved indications.

Discussing the ACS approval for a 2.5mg version of Xarelto, Bayer HealthCare's head of global development Dr Kemal Malik said the EC's decision “re-enforces the compelling profile of the product, further extending its clinical value in preventing arterial blood clots”.

The decision was backed by the ATLAS ACS study – the same study that Bayer and Johnson & Johnson had used to support the drug's failed bid for approval in the US.

According to Bayer, this study, which involves more than 15,500 patients, demonstrated that adding a 2.5mg dose of Xarelto to standard antiplatelet therapy significantly reduced cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone.

A 5mg dose of Xarelto was also tested in the ATLAS ACS study, but this increased dose came with a higher bleeding risk that was considered by European regulators to outweigh the drug's benefits.

28th May 2013

From: Sales



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