Boehringer Ingelheim has filed for approval of its anticoagulant Pradaxa for the treatment and prevention of venous thromboembolism (VTE) in Europe.
Specifically, the pharma company has submitted Pradaxa (dabigatran etexilate) for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE.
If approved the new indication will boost the patient population addressed by the thrombin inhibitor, which is already registered for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement or total knee replacement surgery.
The submission is based on the results of four trials which have shown that the drug is as effective as warfarin in treating and preventing DVT and PE, but is associated with fewer bleeding complications.
VTE opens up a big new market for Pradaxa, as it affects around 2.5 million patients every year in the US and EU, with two-thirds of cases in institutionalised patients.
Meanwhile, annual costs are estimated to be more than €3bn in Europe for total direct costs associated with VTE and up to $15.5bn in the US for diagnosis and treatment of DVT and PE, according to Boehringer.
Approval would also help Boehringer as it jostles in the marketplace with other oral anticoagulants such as Bayer’s Xarelto (rivaroxaban) and Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban), both Factor Xa inhibitors, which are also positioned as safer and easier-to-administer alternatives to warfarin.
Opinions differ on the eventual outcome of the three-way battle, although a number of analysts have out Eliquis out in front with around 60 per cent of the market, with Pradaxa and Xarelto fighting over the remainder.
Xarelto was approved for PE and DVT prevention last year, while Eliquis has not yet been submitted for approval in this setting, although it recently showed efficacy in the AMPLIFY-EXT trial as a long-term VTE therapy.