February 05, 2016
EMA Reaffirms Positive Benefit-Risk Balance of Bayer's Xarelto® for Stroke Prevention in Patients with Atrial Fibrillation
the positive benefit-risk balance of Bayer's Xarelto® for stroke prevention in
patients with atrial fibrillation. This outcome concludes a CHMP (Committee for
Medicinal Products for Human Use) procedure that was initiated to assess
whether a potential malfunctioning of the INR device used in the ROCKET AF
trial had any impact on the study results. Bayer and its development partner
Janssen have undertaken thorough analyses, which were shared with Health
Authorities, in particular EMA and the FDA. Separately, the re-analysis
conducted by the ROCKET AF Executive Committee, who ran the ROCKET AF trial,
was recently published online in the New England Journal of Medicine.
The EMA has concluded that a defect with the INR device used in the ROCKET
study does not change its conclusions on the overall safety or benefit-risk
balance of Xarelto (rivaroxaban). In particular, the EMA in their announcement
states that "after further analyses of the ROCKET study data taking into
account the defect in the INR device, EMA's Committee for Medicinal Products
for Human Use (CHMP) concluded that any incorrect measurements obtained with
the defective device would have had only a marginal effect on the study
results, and the safety of Xarelto remains unchanged. In addition, data from
other large studies confirmed the comparative safety of the medicine and showed
similar rates of bleeding in their warfarin groups." The EMA therefore states:
"This means that Xarelto can continue to be used as before, in line with the
current prescribing information."
"As a member of the ROCKET AF Executive Committee but equally important as a
physician the re-analysis provides me with additional confidence in the
strength and robustness of the ROCKET AF trial. It is valuable to be able to
provide reassurance to my fellow colleagues but also to our patients and their
carers about the evidence for the benefits of rivaroxaban in protecting people
with atrial fibrillation from the risk of a stroke," said Professor Keith A. A.
Fox, Duke of Edinburgh Emeritus Professor of Cardiology of the University of
Edinburgh, Scotland and Member of the ROCKET AF Executive Committee.
"We are very pleased with EMA's assessment confirming the positive benefit-risk
profile of Xarelto for stroke prevention in patients with atrial fibrillation,"
said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer
AG's Pharmaceuticals Division and Bayer Chief Medical Officer. "EMA's
assessment follows the conclusions from Bayer and Janssen and those from the
independent ROCKET AF Executive Committee that the ROCKET AF data are robust.
The re-analyses are reassuring and will provide physicians with additional
confidence to prescribe Xarelto for their patients with atrial fibrillation at
risk of stroke."
In December 2014, Alere Inc. issued a device correction notice for their INR
device that is used to monitor INR values in patients using warfarin. Bayer and
Janssen were not notified at that time. When the companies became aware of the
device correction notice, in September 2015, they promptly reached out to the
manufacturer for more information. Upon confirmation from the manufacturer that
the devices used in ROCKET AF should have been included in the device
correction notice, Bayer and Janssen proactively and quickly notified health
authorities around the world, including EMA and the FDA and conducted a number
of analyses to assess any potential impact on the primary efficacy and safety
results of the ROCKET AF clinical trial. These analyses confirm the results of
the ROCKET AF study and the positive benefit-risk profile of Xarelto in
patients with non-valvular atrial fibrillation. During the conduct of the
ROCKET AF trial (2006-2010), the INR devices were approved for use by the FDA
and available on the market in the US and EU (CE mark).
Xarelto is an important anticoagulant used to treat and reduce the risk of
life-threatening blood clots. Beyond ROCKET AF, the companies have evaluated
the performance of Xarelto in more than 91,000 patients across its approved
indications in real-world research following the medicine's approval, and study
after study continues to confirm that Xarelto is performing as expected with a
positive benefit-risk profile. This is further supported by evidence generated
through independent post-marketing studies conducted by regulators and
clinicians as well as the study XANTUS which investigated the use of Xarelto in
more than 6,700 patients with AF for stroke prevention in routine clinical
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral
anticoagulant (NOAC) and is marketed under the brand name Xarelto®. Xarelto is
approved for seven indications, protecting patients across more venous and
arterial thromboembolic (VAT) conditions than any other NOAC:
- 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
- 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 130 countries.
Rivaroxaban was discovered by Bayer, and is being jointly developed with
Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by
Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research &
Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen
Pharmaceutical Companies of Johnson & Johnson).
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 www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com
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