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news.The European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Boehringer Ingelheim's Pradaxa (dabigatran etexilate) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as the prevention of recurrent DVT and PE in adult patients.
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The CHMP positive opinion follows recent US FDA approval of the drug for treatment of and reduction in the risk of recurrent DVT and PE.
Both DVT and PE are major medical conditions with almost one in three PE patients die within three months and four out of ten patients suffer a repeat blood clot within ten years of the first.
In addition, PE as a consequence of a DVT is the leading cause of preventable death in hospital and effective and safe treatment is necessary to avoid this as well as to reduce patient’s risk of experiencing another blood clot.
Boehringer Ingelheim chief medical officer Professor Klaus Dugi said the company is happy with this recommendation for European approval, which is a major step towards broadening the indications for which Pradaxa can be used and extending its proven benefits to more patients.
"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," Dugi said.
The positive opinion is based on results from four robust Phase III clinical trials involving almost 10,000 patients that showed the efficacy of Pradaxa in the treatment and prevention of repeat DVT and PE compared to warfarin.
In the EU, the drug 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.
Image: EMA recommends approval of Pradaxa for treatment of deep vein thrombosis and pulmonary embolism. Photo: courtesy of m_bartosch / freedigitalphotos.net