FDA approves Boehringer’s Pradaxa
pharmafile | October 20, 2010 | News story | Sales and Marketing | Boehringer, Pradaxa, atrial fibrilation
Boehringer Ingelheim’s Pradaxa has stolen a march over its rivals by being the first new oral anticoagulant to reach the US market in 50 years.
The novel, oral direct thrombin inhibitor, for stroke risk reduction in patients with non-valvular atrial fibrillation (AF), is part of a new class of drugs seeking to replace warfarin.
Boehringer’s chairman Professor Andreas Barner said: “This first approval of Pradaxa for stroke risk reduction in atrial fibrillation in the US marks a new era for stroke prevention in atrial fibrillation.
“We expect that dabigatran etexilate [Pradaxa] will in the coming months become available to patients with atrial fibrillation in more countries, internationally.”
Pradaxa is part of a new class of oral anticoagulants, including Bayer’s Xarelto and Pfizer/BMS’s apixiban that could herald the disappearance of warfarin clinics in the UK.
Both drugs are Factor Xa inhibitors but are yet to gain regulatory approval. Bayer’s Xarelto recently won this year’s coveted Prix Galien award for the most innovative drug.
Pradaxa is already sold in Europe to prevent clots after hip and knee surgery, as is Xarelto.
Warfarin, which was originally developed as rat poison, is currently the only oral anti-clotting agent for both post-surgery prevention of venous thromboembolism (VTE) and atrial fibrillation prevention, but it interacts with many common medications and its use requires close GP monitoring.
Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s center for drug evaluation and research, said: “People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain.
“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”
In September, an FDA advisory panel voted 9-0 to recommend approval of Pradaxa.
Recent results from the late stage RE-LY trial showed that in patients with AF, Pradaxa significantly reduced the risk of stroke and systemic embolism by 34% compared to warfarin, but with comparable rates of major bleeding (the main sticking point in the trial).
The drug achieves its anti-thrombotic effects by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation.
For pharma the warfarin replacement market is expected to be worth between $10 billion and $20 billion a year.
Ben Adams
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