The FINANCIAL -- Bayer HealthCare’s oral anticoagulant Xarelto has been
recommended for approval by the European Committee for Medicinal
Products for Human Use (CHMP) for both the prevention of stroke and
systemic embolism in adult patients with non-valvular atrial
fibrillation (AF), as well as for the treatment of deep vein thrombosis
(DVT) and prevention of recurrent DVT and pulmonary embolism (PE)
following an acute DVT in adults.
“The recommendation by the CHMP to approve rivaroxaban in these two additional indications is a significant milestone for our company,” said Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer. “We expect that we will soon be able to provide patients and physicians in Europe with an effective alternative for the prevention of strokes in patients with atrial fibrillation as well as a new, convenient single drug approach to the treatment of DVT.”
The decision of the European Commission is expected in the fourth quarter 2011 and an approval would make rivaroxaban the only new oral anticoagulant available for adult patients across three indications in all EU member states, including:
Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation with one or more risk factors
Treatment of DVT and prevention of recurrent DVT and PE following an acute DVT
The prevention of VTE in patients undergoing elective hip or knee replacement surgery
“The decision to recommend rivaroxaban for these new indications speaks to its validated efficacy and safety in the management of potentially deadly blood clots across a wide range of arterial and venous settings,” said Professor Ajay Kakkar, Professor of Surgery, University of London. “This is important for patients and their physicians because rivaroxaban offers a highly effective and well tolerated therapy option. Importantly, it is not restricted by the limitations of current therapies, including unpredictable anticoagulation, frequent monitoring, drug and food interactions, and the inconvenience associated with regular injections.”
“Patients have waited over 50 years for new treatments which offer improved outcomes to traditional therapies that can have limitations such as routine monitoring and regular injections, as well as dietary challenges and interactions with other treatments,” said Eve Knight, Co-Founder and CEO of AntiCoagulation Europe (ACE). “Today’s recommendation for rivaroxaban is another welcome signal that the era of advanced oral anticoagulants which offer protective benefits beyond traditional therapies has arrived in Europe.”
The CHMP recommendation to approve rivaroxaban for stroke prevention in atrial fibrillation is based on the important clinical benefits demonstrated in ROCKET AF, a rigorous, 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.
The positive recommendation for rivaroxaban in the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT, follows submission of data from the Phase III EINSTEIN-DVT study presented at the European Society of Cardiology (ESC) Congress in August 2010, as well as data from the Phase III EINSTEIN-Extension study, presented in December 2009 at the 51st Annual Meeting of the American Society of Hematology (ASH). Both EINSTEIN-DVT and EINSTEIN-Extension were published in the New England Journal of Medicine in December 2010.
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