Boehringer Ingelheim has received a huge boost with the news that a US advisory panel has unanimously backed the German firm's oral anticoagulant Pradaxa for the reduction of strokes.
The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted 9 to 0 in favour of approving Pradaxa (dabigatran) for stroke prevention in patients with atrial fibrillation. They looked principally at the 18,113-patient RE-LY study which showed that the drug convincingly beat warfarin and could overtake the latter as the treatment of choice.
Last week, ahead of the meeting, FDA staffers argued that the higher dose of Pradaxa, 150mg, should be approved with a superiority claim over warfarin, not a 110mg dose. The committee did not vote on which dose to recommend, but four panellists reportedly supported only the higher dose while six backed both doses in order to give doctors flexibility.
The FDA usually follows panel recommendations and a final decision on Pradaxa is due by October 19. The backing clearly puts Boehringer ahead of the large pack of drugmakers focusing on the warfarin replacement market which analysts believe could be worth as much as $20 billion.
That pack is led by Bayer/Johnson's Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer's apixaban. Further back are Daiichi Sankyo's edoxaban and Merck & Co's betrixaban.
Unsurprisingly, Christopher Corsico, medical director at Boehringer Pharmaceuticals in the USA, said the family-owned firm is pleased with the committee’s unanimous recommendation, "which marks an important step in advancing care for patients with AF". He added that dabigatran "will offer patients and doctors the first new treatment option for stroke prevention in AF in more than 50 years" and "we look forward to working with the FDA as it finalises its review".
Pradaxa is already available in over 40 countries and was approved in the European Union in 2008 for the less-lucrative indication of the prevention of venous thromboembolism following hip or knee surgery.