The European Society of Cardiology (ESC) today issued revised practice guidelines for the management of atrial fibrillation (AF), including guidance on the role of a novel oral treatment, dabigatran etexilate, for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).
“Boehringer Ingelheim has a long term commitment to the treatment and prevention of stroke. The decision by the US FDA to grant a priority designation review is an important step in making dabigatran etexilate available for patients with atrial fibrillation to prevent them from strokes.”
At the same time, Boehringer Ingelheim confirms that the U.S. Food and Drug Administration (FDA) granted a priority review designation for Boehringer Ingelheim's novel oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke in AF. A priority review designation is given to new drugs that are expected to offer major advances in treatment, or provide a treatment where no adequate therapy exists. An FDA advisory committee will meet on Monday, September 20th, to review and discuss dabigatran etexilate data.
In addition to the US, the registration process for dabigatran etexilate is underway in Europe, Japan and other countries. The company expects to receive marketing authorization for dabigatran etexilate in first countries by end of 2010 or beginning of 2011.
RE-LY® study
All applications, including the FDA New Drug Application (NDA) are based on the results of the pivotal Phase III RE-LY® study (Randomized Evaluation of Long-term anticoagulant therapY), published in the New England Journal of Medicine in August 2009, comparing the efficacy and safety of two doses of dabigatran etexilate with warfarin (titrated to INR 2.0 to 3.0) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.