Approval requested at EMA for extension of indication for dabigatran etexilate

News - June 25, 2013

An application has been submitted to the European Medicins Agency (EMA) to allow use of dabigatran etexilate (Pradaxa®, Boehringer Ingelheim) for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE.  

Dabigatran etexilate has already been approved 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.
Four global phase III studies investigated the efficacy and safety of dabigatran etexilate and found it to be as effective as warfarin, with lower rates of clinically relevant bleeding and total bleeding for patients with DVT or PE. Dabigatran etexilate prevented 9 out of 10 episodes of recurrent DVT and PE [1,2].

Dabigatran etexilate currently does not have approval for the acute treatment or prevention of recurrent DVT and PE. The RE-VOLUTION® clinical trial programme investigates dabigatran etexilate in multiple indications.

Press release Boehringer Ingelheim
1Schulman S, et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709-18.
2Schulman S, et al. Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342-52. 

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