CHMP, the European Committee for Medicinal Products for Human Use has approved the oral anticoagulant Xarelto (rivaroxaban) for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults. The medication has also been recommended for stroke prevention and for the treatment of adult patients with non-valvular atrial fibrillation with non CNS systemic embolism.
Bayer HealthCare, the maker of Xarelto, informs that over 70,000 individuals in the United Kingdom suffer from venous thromboembolism each year – DVT and/or PE. Approximately 25,000 patients are thought to die annually in the UK from hospital-acquired DVT annually. Three-quarters of a million people in the UK are affected by atrial fibrillation.
Patients with atrial fibrillation are five times more likely to suffer a stroke.
Professor Keith Fox, Professor of Cardiology at the University of Edinburgh, said:
“The decision to recommend rivaroxaban for these new indications underscores the positive risk benefit profile seen in trials testing rivaroxaban against the current standard of care to prevent blood clots in patients with non-valvular AF and DVT. This news is important for patients and their physicians because there is a clear need for effective therapy options which are not restricted by the limitations of current treatments.”
Xarelto is a Factor Xa inhibitor – a medication which acts at a crucial point in the blood-clotting process to prevent the formation of blood clots. Xarelto’s main advantage over other anticoagulants is that it does not require such close monitoring or dose adjustments.
Low molecular weight heparin injections is the current standard care of treatment for VTE, followed by warfarin, a VKA (vitamin K antagonist). Warfarin is also the standard treatment for stroke prevention in patients with atrial fibrillation.
Disadvantages of heparins and VKAs – heparins are injected, which is more inconvenient and uncomfortable compared to oral medications. VKAs may require regular changes of doses, they also have several interactions with other drugs and foods.
Advantage of Rivaroxaban – this medication, taken as a single oral drug, has the potential to replace the heparin + VKA approach. Apart from being much more convenient and less uncomfortable (no injection), there are fewer interactions with foods and other drugs.
EMA (the European Medicines Agency) has the final say in approving medications. The CHPM’s recommendation is not binding. However, EMA usually goes along with what it recommends. Bayer says it expects European Union approval for rivaroxaban during the fourth quarter of this year, making it available in 27 EU member countries.
Eve Knight, Co-Founder and CEO of AntiCoagulation Europe (ACE), said:
“Patients have waited over 50 years for new treatments which offer an alternative to traditional therapies that can have limitations such as routine monitoring and regular injections, as well as dietary challenges and interactions with other treatments. Today’s recommendation for rivaroxaban is another welcome signal that alternative anticoagulants have arrived in Europe.”
CHPM members assessed data from the Phase 3 EINSTEIN-DVT study, which was presented at the European Society of Cardiology last year, as well as data from an extension of the same study (Phase III EINSTEIN-Extension study), which was published in NEJM (New England Journal of Medicine).
On its website, Bayer added:
“The CHMP recommendation to approve rivaroxaban for the prevention of stroke and non CNS systemic embolism in patients with non-valvular AF is based on the important clinical benefits demonstrated in ROCKET AF, a double-blind global Phase III study that compared once-daily rivaroxaban with warfarin in more than 14,000 patients. The results from the ROCKET AF trial were presented at the American Heart Association (AHA) Congress in November 2010 and published in the New England Journal of Medicine in August 2011.”
Rivaroxaban is already approved in Europe for the prevention of VTE in patients (adults) who undergo elective knee or hip replacement surgery.
Venous thromboembolism (VTE) occurs when a blood clot obstructs a blood vessel – it is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common and often potentially fatal disorder that affects both hospitalized and non-hospitalized individuals, it recurs often, is commonly overlooked, and can lead to long-term complications, including CTPH (thromboembolic pulmonary hypertension) and PTS (post-thrombotic syndrome).
Five times more people die from VTE in the UK than the combined total from cancer, AIDS, and vehicle accidents.
Deep Vein Thrombosis (DVT) is when a blood clot forms in a deep vein which totally or partly blocks the flow of blood. Approximately 1 in every 1,000 individuals in the UK is affected by DVT annually in the UK. A major proportion of these patients have underlying health problems or underwent major surgery – however, Bayer informs that “A significant minority have no known pre-existing risk factors and can develop apparently spontaneous events.”
A deep vein thrombosis in the right leg. Note the swelling and redness.
Most people with a venous blood clot will only experience a DVT. However, DVT can lead to complications, such as PE, which can be fatal if the clot becomes dislodged and makes its way to the lungs and blocks a blood vessel there. Even if there is no PE, DVT alone can be devastating and costly and can lead to post-thrombotic syndrome and a greater risk of further blood clots in the future.
Written by Christian Nrodqvist