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Boehringer Ingelheim's Pradaxa approved in Europe

Published on 28/03/08 at 11:40am

European regulators have approved Boehringer Ingelheim's novel anti-clotting pill Pradaxa, paving the way it to be launched in the coming weeks.

Pradaxa (dabigatran) is a once-daily pill and could make a major impact in the anti-thrombosis market by providing a convenient alternative to warfarin (which requires close monitoring) and to the current standard treatment Clexane, Sanofi-Aventis' once-daily injection.

In trials Pradaxa was shown to be as effective and safe as Clexane in preventing venous thromboembolism (VTE) and all cause mortality following total hip and total knee replacement surgeries.

The European Commission's market authorisation covers all 27 EU member states and the product will be launched first in Germany and the UK.

Pradaxa is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.

Dr Andreas Barner, member of the board of Boehringer Ingelheim and responsible for research, development and medicine, said: "This first licence for our novel oral anticoagulant Pradaxa marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi (blood clots).

"In addition, we remain confident in the potential for Pradaxa to satisfy the unmet medical needs of even more patients and physicians in the future as we continue to invest in our extensive RE-VOLUTION clinical trial programme investigating Pradaxa across four further therapeutic areas."

The programme includes the largest atrial fibrillation outcomes trial to date, as well as studies into Pradaxa's use as a treatment of acute VTE, the secondary prevention of VTE and prevention of cardiac events in patients with acute coronary syndrome.

EU approval for the drug's first indication also gives it a few months lead over a rival drug, Bayer's Xarelto, another novel oral treatment that is seeking a licence to treat post-surgery (VTE).

Both Pradaxa and Xarelto are predicted to become blockbusters earning in excess of $1billion annually, but just how much they will earn will depend on the number of indications they can gain, and in convincing doctors they are safe.

Drug safety is a key issue in the field after the 2006 withdrawal of AstraZeneca's VTE treatment Exanta (ximelagatran) due to concerns over side effects.

Exanta was a first-in-class direct thrombin inhibitor, the same class as Pradexa and Boehringer is widely studying its drug's safety.

Its clinical trial programme involves more than 34,000 patients worldwide. An independent committee has frequently monitored patients' liver enzyme elevations in all its phase III trials, and suggests very few patients suffered worrying elevations while on its drug.

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