Boehringer Ingelheim has cause for celebration this morning after the US Food and Drug Administration approved the German firm's bloodthinner Pradaxa for stroke risk reduction in non-valvular atrial fibrillation.
The approval is unsurprising seeing as how the the FDA's Cardiovascular and Renal Drugs Advisory Committee has voted 9 to 0 last month in favour of approving Pradaxa (dabigatran) for the aforementioned indication. The green light is principally based on the 18,113-patient RE-LY study which showed that the drug reduced the risk of stroke and systemic embolism by 35% beyond the reduction achieved with warfarin, the longtime standard of care, in addition to reductions in life-threatening and intracranial bleeding.
Boehringer noted that the FDA thumbs-up marks the first approval of a new oral anticoagulant in the USA in more than 50 years. Pradaxa will now be available to "a broad spectrum of patients", with the 150mg bid dose approved for all patients "except for a small subset with severe renal impairment (creatinine clearance 15-30 mL/min) where the approved dose is 75mg bid.
Boehringer chairman Andreas Barner said the approval "marks a new era for stroke prevention in AF" and is an important event in the 125-year history" of the privately-owned firm. He added that Pradaxa, which was approved in the European Union in 2008 for the less-lucrative indication of the prevention of venous thromboembolism following hip or knee surgery, will "in the coming months become available to patients with atrial fibrillation in more countries, internationally.”
Analysts believe Pradaxa will overtake warfarin as the treatment of choice. The latter is highly effective in reducing the risk of stroke but is a very difficult treatment to use because of its interaction with various drugs, food types and the need for continuous monitoring.
Stuart Connolly of the McMaster University in Canada and co-principal investigator of RE-LY, said the approval of Pradaxa "provides for the first time an effective, flexible and convenient treatment option in the USA, which will be especially important for the large group of patients who currently do not take any treatment because they cannot tolerate or refuse to take warfarin".
With this approval, Boehringer has stolen a march in the USA on Bayer/Johnson & Johnson's Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer's apixaban.