Earlier in 2014, the US Food and Drug Administration (FDA) had approved Pradaxa to treat patients with DVT and PE.
The company said that 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.
Boehringer Ingelheim chief medical officer Professor Klaus Dugi said the company is happy 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.
"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," Dugi said.
The EC approval follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
It is based on results from three robust phase III clinical trials that showed 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.
Image: Boehringer’ Pradaxa is approved by both European Commission and FDA to treat deep vein thrombosis and pulmonary embolism. Photo: courtesy of foto76/ freedigitalphotos.net