September 15, 2017
Bayer receives positive CHMP opinion for rivaroxaban 10 mg once daily for the extended prevention of venous thromboembolism
Rivaroxaban 10 mg once daily significantly reduces the risk of recurrent venous thromboembolism compared with aspirin 100 mg once daily after at least six months of standard anticoagulation therapy / Positive CHMP Opinion is based on data from the Phase III EINSTEIN CHOICE study / Final European Commission decision expected by November 2017Berlin, September 15, 2017 - Bayer AG announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
has granted a positive opinion to update the label for its oral Factor Xa
inhibitor Xarelto® (rivaroxaban) to include a 10 mg once daily dose for the
extended prevention of recurrent venous thromboembolism (VTE). This label
update will apply to patients who have already received at least six months of
standard anticoagulation therapy. Once approved, this will provide physicians
with an additional treatment option alongside the 20 mg once daily dose already
licensed in this indication. The final European Commission decision is expected
by November 2017.
"Patients who have previously suffered a VTE are often at increased risk of
experiencing another event if anticoagulant treatment is stopped," said Dr.
Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical
Division and Head of Development. "Today's positive CHMP opinion takes us one
step closer to providing physicians with an additional therapeutic option
enabling them to select the extended treatment that best suits the
benefit-risk-assessment of the individual patient."
VTE, which includes pulmonary embolism (PE), a clot that travels to the lung,
and deep vein thrombosis (DVT), a blood clot in a deep vein (often in the
legs), has a significant global impact and is the third most common cause of
cardiovascular death worldwide, after heart attack and stroke. The current
treatment recommendation for the prevention of recurrent venous thromboembolism
is anticoagulation therapy for three months or longer, depending on the balance
between the risk of recurrent VTE and the risk of bleeding.
The positive CHMP opinion is based on data from the Phase III EINSTEIN CHOICE
study, which showed that both 10 mg and 20 mg once daily dosages of rivaroxaban
significantly reduced the risk of recurrent VTE compared with aspirin 100 mg
once daily (acetylsalicylic acid) in patients who had previously completed 6 to
12 months of anticoagulation therapy for treatment of pulmonary embolism (PE)
and / or symptomatic deep vein thrombosis (DVT).
All three treatment groups showed comparable and low rates of major bleeding
(the principle safety outcome). Data from EINSTEIN CHOICE were published in The
New England Journal of Medicine in March 2017(1).
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 pulmonary embolism (PE) in adults
- The treatment of deep vein thrombosis (DVT) in adults
- The prevention of recurrent PE and DVT 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 about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com
(1) J.I.Weitz, A.W.A. et al. N Engl J Med 2017; 376:1211-22
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