Boehringer Ingelheim submits Pradaxa for new EU indication

Boehringer Ingelheim has announced that it is filing for European regulatory approval of new indications for its oral anticoagulant Pradaxa.

The European Medicines Agency will review the drug as a potential option for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for the prevention of recurrent DVT and PE.

Clinical trial data from four phase III trials has suggested that Pradaxa can be as effective as the standard of care warfarin, while offering safety advantages in terms of minimising the risk of bleeding events.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "Our studies have demonstrated that Pradaxa offers an effective treatment with significant safety benefits compared to warfarin both for acute treatment as well as in the long-term prevention of recurrent events."

Part of a new class of oral anticoagulants, Pradaxa can boast in-market experience spanning more than 1.6 million patient years in all currently licensed indications.

Earlier this month, data from the RELY-ABLE trial demonstrated its strong long-term safety performance when used in the treatment of atrial fibrillation.