Boehringer Ingelheim receives EU approval for new Pradaxa indication

Boehringer Ingelheim has announced that its multipurpose anticoagulant Pradaxa has been approved in a new indication in Europe.

The drug has been ratified for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) by the European Commission, following a similar decision by the US Food and Drug Administration earlier this year.

Data from three robust phase III clinical trials has demonstrated the safety and efficacy of Pradaxa in this specification compared to warfarin, while a fourth study showed a 92 percent reduction in the risk of recurrent blood clots compared to placebo.

Professor Klaus Dugi, chief medical officer at Boehringer Ingelheim, said: "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."

Clinical experience of Pradaxa equates to over 2.9 million patient-years in all licensed indications worldwide. Earlier this year, Jordan became the 100th country to approve the drug for use.