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Xarelto gets new atrial fibrillation label in Europe

First oral anticoagulant to gain EU approval in indication

Bayer Xarelto rivaoxaban

Bayer and Janssen's Xarelto has become the first novel oral anticoagulant (NOAC) to get EU approval for broad use in a procedure used to restore normal heart beat rhythm in atrial fibrillation (AF) patients.

The new labelling - which was backed by the CHMP last month - is based on the results of the exploratory X-VeRT trial, which involved more than 1,500 non-valvular AF patients undergoing the procedure - called cardioversion.

Crucially, the trial showed that patients might be able to undergo cardioversion earlier with Xarelto than with vitamin K antagonist anticoagulants (VKAs) such as warfarin, while treatment with the NOAC was simpler as it can be given once daily and does not require routine monitoring for anticoagulation status (INR checks).

Xarelto was also associated with a trend towards a reduced risk of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction and cardiovascular death in the trial, although the study was too small for this to achieve statistical significance.

Patients with AF have turbulent blood flow in the heart, which can lead to the formation of dangerous blood clots, so routinely receive anticoagulants.

Cardioversion involves applying an electric current or a drug to coax the heart back into a normal sinus rhythm, and without anticoagulation patients undergoing the procedure are at increased risk of complications, including strokes.

Patients undergoing cardioversion in the X-VeRT study were split into two groups, one receiving the procedure early (one to five days after enrolment) and another, delayed group treated after three weeks of documented, effective anticoagulation and within eight weeks of enrolment.

Patients on Xarelto could be cardioverted earlier in the delayed arm than those on VKAs, mainly because of difficulties in achieving reliable anticoagulation in the latter group. All told, 77% of those in the rivaroxaban group and only 36.3% of those who received VKA were cardioverted within the target time range.

The results also showed that in patients undergoing early cardioversion, Xarelto was a safe alternative to warfarin.

The EMA has decided to include the data on the label for Xarelto - even though time to cardioversion was not a pre-specified outcome of the study - in order to give cardiologists information about the findings while the X-VeRT trial and real-world data programme continues to generate data.

"With warfarin, patients will often move in and out of the therapeutic range for optimal anticoagulation often requiring postponement of their procedure or leading to increased risk of thromboembolic events like stroke," commented lead investigator Riccardo Cappato of the University of Milan.

"The X-VeRT study showed Xarelto to be an effective and well-tolerated alternative to vitamin K antagonists with a practical advantage over VKAs," he added.

The label update is a boost for Xarelto as it jostles for market share with other NOACs, including Boehringer Ingelheim's Pradaxa (dabigatran), Pfizer/Bristol-Myers Squibb's Eliquis (apixaban) and the latest entrant into the market - Daiichi Sankyo's Savaysa (edoxaban) - that has just been approved for marketing in the US.

Article by
Phil Taylor

21st January 2015

From: Sales

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