The US Food and Drug Administration has expanded the label on Boehringer Ingelheim's anticoagulant Pradaxa for recurrent deep vein thrombosis and pulmonary embolism.

Specifically, the agency has given the thumbs-up to Pradaxa (dabigatran etexilate) for the treatment of DVT and PE in patients who have been on an injectable anticoagulant for five to ten days, and to reduce the risk of recurrent DVT and PE in those who have been previously treated. It is already approved in the USA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

The latest FDA approval is based on results from Phase III trials which show that Pradaxa is as effective as warfarin with significantly less bleedings and one study also showed a 92% reduction in the risk of recurrent blood clots versus placebo.

Boehringer chief medical officer Klaus Dugi said the approval of these new indications "represents another significant landmark for Pradaxa and this positive news further strengthens our commitment to optimising patient management in the field of anticoagulation". Almost one in three DVT or PE patients die within three months and DVT-related PE is the leading cause of preventable death in hospitals, the company noted.

The green light is a boost for Boehringer across the Atlantic at a time when it is facing over 2,000 lawsuits alleging that the extent of Pradaxa's bleeding risk has been concealed.