Regulators in Europe have finally given the thumbs-up to Boehringer Ingelheim's oral anticoagulant Pradaxa for stroke prevention.
Specifically, the European Commission approved Pradaxa (dabigatran etexilate) for the prevention of stroke in patients with atrial fibrillation at risk of the former condition. While overall the 150mg BID (twice-daily dose) is recommended for the majority of patients, the 110mg BID dose is specifically available for patients aged 80 years or above, for those at increased risk of bleeding and for patients who are co-administered with Pradaxa and the calcium channel blocker verapamil.
The drug is already available to prevent clots after hip and knee surgery and was recommended for approval for the new indication by the European Medicines Agency’s Committee for Medicinal Products for Human Use in April. However, it has taken a little while to get full approval, due to an administrative hiccup by Boehringer but now Pradaxa is the first new drug for 50 years to get the green light for the prevention of AF-related strokes and provide an alternative to vitamin K antagonist therapies, such as long-time standard of care, warfarin.
The company quoted Gregory Lip at the University of Birmingham Centre for Cardiovascular Sciences in the UK as saying that "whilst effective, warfarin has many limitations such as the need for regular monitoring and various food-drug and drug-drug interactions". This means only half of eligible patients receiving warfarin "and fewer than half of these patients being controlled within the desired therapeutic range".
Pradaxa is already approved for the prevention of stroke in AF in the USA, Canada, Japan, Australia and several other countries. Boehringer chairman Andreas Barner noted that the drug "is a result of nearly 20 years of innovative R&D by our scientists" and "we will now ensure that this new breakthrough treatment is made available to physicians and AF patients throughout Europe as soon as possible".
Dr Barner recently told PharmaTimes World News in Berlin that Pradaxa has enjoyed one of the most successful launches ever in the USA and enjoyed 'huge acceptance" among physicians. He believes it is a cost-effective treatment and the company has prepared "price proposals which are reasonable" for Europe's various reimbursement bodies.
The European OK means that Boehringer has stolen a further march on potential rivals, Bayer/Johnson & Johnson's Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer's Eliquis (apixaban).