The European Commission has given a green light to Boehringer Ingelheim’s Pradaxa for use to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), setting it on a par with rival anticoagulants.
Pradaxa (dabigatran) has been cleared for the treatment and prevention of recurrence of DVT and PE in adults, allowing it to compete head-to-head with Bayer/Johnson & Johnson’s Xarelto (rivaroxaban), which has already been approved in this setting, and putting it ahead of Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), which is currently under review by the European Medicines Agency (EMA) in this indication.
All three drugs have been positioned as replacements for warfarin for DVT/PE as they are easier to administer and may be less prone to causing bleeding complications, and, while warfarin remains the most commonly-used drug because of its low price, doctors in Europe are increasingly turning to the new oral anticoagulants.
Direct thrombin inhibitor Pradaxa was the first of the three to come to market, racking up sales of $1.6bn in 2013, but latterly has lost ground to its Factor Xa inhibitor rivals, particularly Xarelto which is now leading the market with sales of around $2bn last year.
To keep pace it is critical for Boehringer to keep extending Pradaxa’s indications, so the EU approval in DVT/PE treatment and secondary prevention – which follows a similar nod from the FDA earlier this year – is a major boost for the company. Pradaxa is already used in patients with atrial fibrillation (AF) and those undergoing orthopaedic surgery.
Having additional treatment options for DVT and PE is also critical as the conditions can be very serious, according to Boehringer. Almost one in three PE patients dies within three months and four out of 10 patients suffer a repeat blood clot within 10 years of the first, it noted.
“Access to this new treatment option is critical for patients as we know that PE as a consequence of a DVT is still the leading cause of preventable death in hospital,” commented the company’s chief medical officer Klaus Dugi.
Boehringer also hopes to extend Pradaxa’s uses into the prevention of recurrent stroke, and recently started a 6,000-patient study in embolic stroke of undetermined source (ESUS).
Boehringer has also started trials of an antidote to Pradaxa, called idarucizumab, which can be used to reverse its anticoagulant effects if a patient develops a serious bleed. Meanwhile Portola Pharmaceuticals is developing a Factor Xa inhibitor antidote, called andexanet alfa, which could be used with both Xarelto and Eliquis.
This article has been amended to note that Pfizer/Bristol-Myers Squibb’s Eliquis is under review in Europe for use in DVT and PE and has not yet been approved