Pradaxa data boosts Boehringer
pharmafile | September 1, 2009 | News story | Research and Development, Sales and Marketing |Â Â Boehringer, PradaxaÂ
Boehringer Ingelheim has unveiled new positive data for its blood-thinner Pradaxa, showing it reduces the risk of stroke compared to rival warfarin, with no increased risk of bleeding.
The company has described the RE-LY study as landmark, while analysts Citigroup said the data has dispelled the long-held belief that it is virtually impossible to improve on the efficacy of well-controlled warfarin.
The new results could speed Pradaxa (dabigatran etexilate) through approval in the indication ahead of rivals, which include Bayer and J&Js Xarelto (rivaroxaban), Pfizer and Bristol-Myers Squibb's apixaban, and Merck & Co's betrixaban.
Professor Stuart Connolly, co-principal investigator of the trial and director of the division of Cardiology at The Population Health Research Institute in Canada, said the results of had exceeded all expectations.
He added: "We now have an oral treatment which offers superior protection from stroke with less bleeding and without the need for routine monitoring. In addition to protecting patients from strokes, we as physicians are especially concerned about life-threatening or disabling bleeding with warfarin due to its narrow therapeutic window. On top of the efficacy, dabigatran has shown equally impressive safety results, offering a wider safety margin."
Up to 3 million people worldwide suffer strokes related to atrial fibrillation (AF) each year. The condition tends to be especially severe and disabling, with half of those people dying within one year.
The RE-LY study was the largest (AF) outcomes trial ever conducted, with 18,113 patients in 44 countries worldwide. The data was presented for the first time at the European Society of Cardiology Congress and published in the New England Journal of Medicine.
It demonstrated that patients taking high dose (150mg) of Pradaxa experienced a 34% lower risk of stroke and systemic embolism, compared with those taking BMS Coumadin (warfarin) or its equivalent generic versions.
Pradaxa also reduced hemorrhagic (bleeding) strokes – a key complication of warfarin – by 20%. The drug is already available in over 40 countries for the primary prevention of venous thromboembolic events in adults who have undergone hip or knee replacement surgery. A new approval could make it blockbuster.
Boehringer said taking into consideration only the potential of stroke reduction, and translating the RE-LY results into clinical practice, Pradaxa could prevent approximately 3,000 strokes per day worldwide compared to well controlled warfarin.
Dr Andreas Barner, the chairman of the board of Boehringer Ingelheim said: "We look forward to expeditiously submitting these results to regulatory authorities around the world so that new options can be made available for millions of patients with atrial fibrillation at risk of stroke."
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