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Bayer’s anticoagulant Xarelto wins new European indications

Gets new approvals in thromboembolism, giving it a potential advantage over Pfizer and Bristol-Myers Squibb's Eliquis

Bayer - Xarelto (rivaroxaban) Bayer's blood thinner Xarelto (rivaroxaban) has been approved by the European Commission (EC) for use in two additional indications.

The drug can now be marketed to prevent stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) who have one or more risk factors.

It was also licensed for use in patients with deep vein thrombosis (DVT) and prevent recurrent DVT and pulmonary embolism (PE) following acute DVT in adults.

Previously, Xarelto had only been approved for the prevention of venous and arterial thromboembolism (VTE) in adults who are undergoing surgery to replace a hip or knee.

The approval was based on the ROCKET-AF trial showing Xarelto was equivalent to current standard treatment warfarin in terms of its safety and efficacy, but had several advantages for patients including its once-daily fixed dosing and the lack of need for routine blood monitoring.

VTE is estimated to cause the deaths of 550,000 people in the EU each year and Eve Knight, co-founder and CEO of the not-for-profit organisation AntiCoagulation Europe (ACE), said the approval was good news for people at risk of blood clots.

She said: “Thrombosis remains a massive burden on patients and healthcare systems across the EU, and the approval of effective alternatives without the limitations of traditional therapies such as routine monitoring, regular injections and dietary challenges represents a much needed evolution in thrombosis management.”

The approvals give Bayer some advantage over Pfizer and Bristol-Myers Squibb (BMS) whose rival product Eliquis (apixaban) is still only approved in the EU for the prevention of VTE in adults who are undergoing surgery to replace a hip or knee.

However, phase III trials have suggested that Eliquis is the first oral anticoagulant to reduce all-cause mortality in AF patients, leading some observers to suggest it could lead the market for warfarin replacements if approved in further indications.

Competition could come sooner than anticipated for Xarelto in the US though following the US Food and Drug Administration's (FDA) decision to give Eliquis priority review for the prevention of stroke in people with non-valvular AF.

Xarelto, which is marketed in the US by Johnson & Johnson, was approved for the same indication by the FDA last month.

20th December 2011

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