Boehringer Ingelheim has received positive opinion from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommending approval of Pradaxa (dabigatran etexilate) for treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients.
The positive opinion follows the recent US Food and Drug Administration (FDA) approval of Pradaxa for treatment of and reduction in the risk of recurrent DVT and PE.
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DVT and PE are major medical conditions and around one in three PE patients die within three months, while four out of ten patients suffer a repeat blood clot within ten years of the first.
PE as a result of a DVT is the leading cause of preventable death in hospital and in order to avoid this, as well as to reduce patient’s risk of experiencing another blood clot, effective and safe treatment is necessary.
Boehringer Ingelheim chief medical officer professor Klaus Dugi said recommendation for European approval is a major step towards broadening the indications that 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.
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By GlobalDataThe CHMP positive opinion is based on results from four Phase III clinical trials involving around 10,000 patients that showed the efficacy of Pradaxa in the treatment and prevention of repeat DVT and PE compared with warfarin.
Results showed that DVT or PE patients taking Pradaxa experienced significantly lower rates of bleeding compared with those taking warfarin,
Data from these trials also showed a 92% reduction in the risk of recurrent blood clots versus placebo.
Pradaxa is also approved in the European Union (EU) 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.
The drug is already approved for stroke prevention in patients with atrial fibrillation and prevention of venous thromboembolism in patients undergoing total hip or knee replacement surgery.
Image: Boehringer Ingelheim Center (BIC), the corporate headquarters building in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.
