Boehringer Ingelheim today announces that Pradaxa® (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). The U.S. Food and Drug Administration (FDA) approved Pradaxa® for DVT and PE patients earlier this year. DVT and PE can be very dangerous; 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.
"We are delighted with the European Commission's decision to approve Pradaxa® for DVT and PE patients, confirming the well-studied efficacy and safety profile of Pradaxa®, which has been established in a clinical trial programme in close to 10,000 patients for DVT and PE, and over 40,000 patients across different indications," commented Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "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."
The approval by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency, and is based on results from three robust phase III clinical trials that demonstrated the efficacy of Pradaxa® in the treatment and prevention of repeat DVT and PE compared to warfarin. In a fourth trial, data showed a 92% reduction in the risk of recurrent blood clots in patients treated with Pradaxa® compared to placebo. With regards to safety, results showed that DVT or PE patients taking Pradaxa® experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favourable overall safety profile. Pradaxa® has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).
"This approval for dabigatran is a major advance for DVT and PE patients and their physicians," said Professor Dr. Stavros Konstantinides, Deputy Scientific Director of the Centre for Thrombosis and Haemostasis of Johannes Gutenberg University, Mainz, Germany. "Clinical trial results show that dabigatran has a favourable safety profile compared to warfarin, while offering similar efficacy for the treatment and prevention of recurrence of DVT and PE. The added benefits of convenience and a simple fixed dose regimen will appeal to patients and their physicians alike."
Pradaxa® is convenient for patients as it does not require routine dose monitoring, nor a mandatory dose change during the course of treatment. DVT and PE patients can start taking Pradaxa® in a simple fixed dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin (LMWH).
Clinical experience of Pradaxa® equates to over 2.9 million patient-years in all licensed indications worldwide. Pradaxa® has already been available for more than six years and is approved in over 100 countries to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Pradaxa® 150mg bid is the only NOAC, study of which (RE-LY®) has shown a significant reduction in the incidence of both ischaemic and haemorrhagic strokes versus warfarin in patients with NVAF. Ischaemic strokes, which account for nine out of 10 strokes experienced by patients with AF, can have devastating consequences and are often fatal or severely disabling. RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. Pradaxa® 110mg bid, which is indicated for certain patients, showed non-inferior efficacy versus warfarin for reducing risk of stroke. Pradaxa® is also approved for primary prevention of VTE (venous thromboembolism, the collective term for DVT and PE) in patients who have undergone elective total hip or total knee replacement surgery.