Pradaxa approved for stroke prevention in Europe
pharmafile | August 9, 2011 | News story | Sales and Marketing | Pradaxa, atrial fibrillation, direct thrombin inhibitor
Boehringer Ingelheim’s Pradaxa has become the first drug in 50 years to be approved in Europe for stroke prevention in atrial fibrillation (AF) patients.
This licence extension for Pradaxa (dabigatran etexilate) had been expected since the oral anticoagulant was recommended by the CHMP in April.
Pradaxa is already approved for preventing blood clots in adults who have undergone elective total hip or elective total knee replacement surgery.
But it can now be used in the EU for the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors – an indication it has already achieved in the US, Canada, Japan and Australia.
“It is a result of nearly 20 years of innovative research and development by our scientists,” said Boehringer’s chairman Andreas Barner.
“We will now ensure that this new breakthrough treatment is made available to physicians and AF patients throughout Europe as soon as possible,” he added.
Along with Bayer’s Xarelto and Pfizer/BMS’s apixiban, the direct thrombin inhibitor is part of a new class of drugs whose manufacturers’ eyes are on replacing the longstanding standard of care, warfarin.
They are helped by various sticking points with warfarin treatment: it requires regular monitoring, and there are food-drug and drug-drug interactions which mean that only half of eligible patients actually receive it.
In the RE-LY trial, which included 18,000 patients, Pradaxa 150mg reduced the risk of stroke and systemic embolism by 35% and significantly lowered the risk of intracranial bleeding compared to warfarin.
Up to three million people worldwide suffer strokes related to AF each year. “AF-related strokes are particularly severe and disabling, with one half of this population dying within one year after a stroke,” explained Trudie Lobban, chief executive of the AF Association.
While the 150mg bid dose of Pradaxa is most commonly recommended, 110mg is available for those aged 80 years or above, or for patients at increased risk of bleeding and for those given Pradaxa with the calcium channel blocker verapamil.
Adam Hill
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