INGELHEIM, Germany - Monday, April 28th 2014 [ME NewsWire]
Recommendation for approval brings DVT and PE patients a step closer to a simple treatment option that is as effective as warfarin with significantly lower rates of bleeding1,2,3
CHMP positive opinion follows recent U.S. FDA approval of Pradaxa® for treatment of and reduction in the risk of recurrent DVT and PE4
Pradaxa® is already approved for stroke prevention in patients with atrial fibrillation and prevention of venous thromboembolism in patients undergoing total hip or knee replacement surgery5
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Boehringer Ingelheim announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Pradaxa® (dabigatran etexilate) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE in adults. The U.S. Food and Drug Administration (FDA) approved Pradaxa® for DVT and PE patients earlier this month.4
DVT and PE are critical medical conditions: almost one in three PE patients die within three months and four out of 10 patients suffer a repeat blood clot within 10 years of the first. Furthermore, PE as a consequence of a DVT is the leading cause of preventable death in hospital.6,7 To avoid this, and to minimise a patient’s risk of experiencing another blood clot, effective and safe treatment is imperative.
“We are very pleased with this recommendation for European approval, which is an important step towards broadening the indications for which Pradaxa® can be used and extending its proven benefits to more patients,” commented Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “With Pradaxa® we aim to offer physicians and patients a new, simple treatment option that is as effective as warfarin, the current standard of care, while providing a favourable overall safety profile.”
The CHMP positive opinion is based on results from four robust phase III clinical trials involving almost 10,000 patients that demonstrated the efficacy of Pradaxa® in the treatment and prevention of repeat DVT and PE compared to warfarin.1,2,3 Data also show a 92% reduction in the risk of recurrent blood clots versus placebo.2 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.3
Pradaxa® has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).2,8,9 Pradaxa® will offer DVT and PE patients, and their physicians, a treatment option that is more convenient than both warfarin and other NOACs investigated in this indication, 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. It 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).10 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.11,12Ischaemic 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.13,14 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.11,12,15 Pradaxa® 110mg bid, which is indicated for certain patients,5 showed non-inferior efficacy versus warfarin for reducing risk of stroke.11,12
In the EU, 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.5
Please click on the link below for ‘Notes to Editors’ and ‘References’:
Boehringer Ingelheim GmbH
Phone: +49 (6132) 77-141575
Fax: +49 6132 – 77 6601