Pharmaprojects R&D Pipeline News Feed
First approval for oral direct Factor Xa inhibitor
16 Sep 2008
Health Canada has approved Bayer's Xarelto (rivaroxaban) as a once-daily tablet for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery.
Rivaroxaban is the first drug in a new class of direct Factor Xa inhibitors to be approved anywhere in the world and to date, it is the only oral anticoagulant to demonstrate superior efficacy over the standard of care, enoxaparin. The closest competition in this class was Bristol-Myers Squibb and Pfizer's apixaban; however this experienced a major setback earlier in the year when it failed to show significant non-inferiority compared to enoxaparin in the Advance-1 Phase III trial. A regulatory filing for the prevention of VTE was initially expected to be submitted in the 2nd half of 2009 with submissions for the treatment of VTE, atrial fibrilation and acute coronary syndrome expected in 2010-12. In third place is Sanofi-Aventis' otamixaban which is currently in Phase II trials for acute coronary syndrome. Regulatory submissions for this indication are expected in 2011.
Rivaroxaban therefore is the clear winner in terms of being the first to market. It will be launched in Canada immediately and approval has been recommended in the EU. It is also awaiting registration in the US for the prevention of DVT and pulmonary embolism in patients undergoing hip or knee replacement surgery.
