European Label Update of Bayer's Xarelto(R) Now Including Guidance for Use in Patients with Atrial Fibrillation Undergoing Cardioversion

PR59248

BERLIN, Jan. 20 /PRN=KYODO JBN/ --

    - Not intended for U.S. and UK Media

    - Label update based on positive CHMP opinion issued in December 2014

    Bayer HealthCare today announced the inclusion of specific guidance for

doctors treating patients with non-valvular atrial fibrillation (AF) undergoing

cardioversion to the European Xarelto(R) (rivaroxaban) Product Information.

This label update provides physicians with important information on the

clinical utility of rivaroxaban in patients with AF who require cardioversion

and is based on the positive CHMP opinion issued in December 2014. It makes

Xarelto the only novel oral anticoagulant with specific label guidance for both

early and delayed cardioversion.

    To view the Multimedia News Release, please click:

http://www.multivu.com/players/uk/7421151-label-update-bayer-xarelto-cardioversion/

    "Providing adequate anticoagulation therapy for patients with AF undergoing

cardio-version is important. 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," said Dr Riccardo Cappato, M.D., Arrhythmia and

Electrophysiology Center, University of Milan, IRCCS Policlinico San Donato,

San Donato Milanese, Milan, Italy and Co-Principal Investigator of the X-VeRT

study. "The Xarelto label update provides physicians with clear guidance for

patients with atrial fibrillation undergoing cardioversion. The X-VeRT study

showed Xarelto to be an effective and well-tolerated alternative to vitamin K

antagonists with a practical advantage over VKAs."

    The label update is based on findings from the X-VeRT study, the first

prospective trial of a novel oral anticoagulant in 1,504 patients with AF

undergoing cardioversion. The results from X-VeRT showed that compared with the

use of VKA, rivaroxaban was associated with a numerical reduction in the risk

of cardiovascular events of 50 per cent in the composite primary efficacy

outcome of stroke, transient ischaemic attack, peripheral embolism, myocardial

infarction and cardiovascular death (0.5% vs. 1.0%; risk reduction: 0.50; 95%

confidence interval: 0.15-1.73), with a numerically lower risk of major

bleeding of 24 per cent in the primary safety outcome (0.6% vs. 0.8%; risk

reduction 0.76; 95% confidence interval: 0.21-2.67). The practical advantage of

using rivaroxaban was demonstrated by the shorter time to cardioversion

compared to VKA, particularly in patients scheduled for delayed cardioversion.

The study, published in the European Heart Journal in September 2014, was

designed to supplement previous findings of rivaroxaban from ROCKET AF and was

not powered for statistical significance.

    About Cardioversion in Patients with AF  

    Patients with AF experience an irregular heartbeat which causes turbulent

blood flow that can lead to the formation of blood clots. Cardioversion is a

common medical procedure undertaken to restore the heartbeat from AF back to

its regular sinus rhythm. Without adequate anticoagulation, these patients are

at risk of thromboembolic complications, with stroke rates of 5-7 per cent.

Current guidelines recommend at least three weeks of effective anticoagulation

with VKAs (target INR 2.0-3.0) prior to cardioversion (or less if a

transesophageal echocardiogram has revealed no thrombus in the left atrial or

left atrial appendage) and four weeks of oral anticoagulation after the

procedure.

    About the X-VeRT Study  

    X-VeRT was a prospective, randomised, open-label, parallel group Phase IIIb

study involving 1,504 patients with hemodynamically stable non-valvular atrial

fibrillation of ＞ 48 hours or unknown duration, recruited from 16 countries.

Anticoagulation naive or experienced patients scheduled for cardioversion were

randomly assigned to rivaroxaban 20mg once daily (15mg once daily if creatinine

clearance was between 30 and 49 mL/min) or INR-adjusted VKA therapy (target INR

2.0-3.0) in a 2:1 ratio. The decision regarding early cardioversion (a goal of

between 1-5 days of rivaroxaban or usual VKA therapy before the procedure) or

delayed cardioversion (rivaroxaban or VKA for 3-8 weeks prior to the procedure)

was taken by the local investigator.

    The X-VeRT study contributes to the extensive investigation program of

rivaroxaban. After its completion, the program will include more than 275,000

patients in clinical trials and real world settings.

    About Xarelto(R) (Rivaroxaban)

    Rivaroxaban is the most broadly indicated novel oral anticoagulant and is

marketed under the brand name Xarelto(R). Xarelto is approved for five

indications across seven distinct areas of use, protecting patients across more

venous and arterial thromboembolic (VAT) conditions than any other novel oral

anticoagulant:

    The prevention of stroke and systemic embolism in adult patients with

non-valvular atrial fibrillation (AF) with one or more risk factors

    The treatment of deep vein thrombosis (DVT) in adults

    The treatment of pulmonary embolism (PE) in adults

    The prevention of recurrent DVT and PE in adults

    The prevention of venous thromboembolism (VTE) in adult patients undergoing

elective hip replacement surgery

    The prevention of VTE in adult patients undergoing elective knee

replacement surgery

    The prevention of atherothrombotic events (cardiovascular death, myocardial

infarction or stroke) after an Acute Coronary Syndrome in adult patients with

elevated cardiac biomarkers and no prior stroke or transient ischaemic attack

(TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA

plus clopidogrel or ticlopidine

    Whilst licences may differ from country to country, across all indications

Xarelto is approved in more than 125 countries.

    Rivaroxaban was discovered by Bayer HealthCare, and is being jointly

developed with Janssen Research & Development, LLC. Xarelto is marketed outside

the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc.

(a Johnson & Johnson Company).

    Anticoagulant medicines are potent therapies used to prevent or treat

serious illnesses and potentially life-threatening conditions. Before

initiating therapy with anticoagulant medicines, physicians should carefully

assess the benefit and risk for the individual patient.

    Responsible use of Xarelto is a very high priority for Bayer, and the

company has developed a Prescribers Guide for physicians and a Xarelto Patient

Card for patients to support best practice.

    To learn more, please visit https://prescribe.xarelto.com

    To learn more about thrombosis, please visit

http://www.thrombosisadviser.com

    To learn more about Xarelto, please visit http://www.xarelto.com

    About Bayer HealthCare  

    The Bayer Group is a global enterprise with core competencies in the fields

of health care, agriculture and high-tech materials. Bayer HealthCare, a

subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of

the world's leading, innovative companies in the healthcare and medical

products industry and is based in Leverkusen, Germany. The company combines the

global activities of the Animal Health, Consumer Care, Medical Care and

Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop,

manufacture and market products that will improve human and animal health

worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31,

2013) and is represented in more than 100 countries. More information is

available at http://www.healthcare.bayer.com

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http://press.healthcare.bayer.com

    Forward-Looking Statements

    This release may contain forward-looking statements based on current

assumptions and forecasts made by Bayer Group or subgroup management. Various

known and unknown risks, uncertainties and other factors could lead to material

differences between the actual future results, financial situation, development

or performance of the company and the estimates given here. These factors

include those discussed in Bayer's public reports which are available on the

Bayer website at http://www.bayer.com. The company assumes no liability

whatsoever to update these forward-looking statements or to conform them to

future events or developments.

    Contact:

    Astrid Kranz,

    Tel. +49-30-468-12057

    E-Mail: astrid.kranz@bayer.com

    Daniela Esser, Tel. +49-30-468-15805

    E-Mail: daniela.esser@bayer.com

    Find more information at http://www.bayerpharma.com.

    sp (2015-0002E)

    SOURCE: Bayer HealthCare