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).
At the same time, Boehringer Ingelheim confirms that the US 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 a marketing authorization for dabigatran etexilate in first countries by end of 2010 or beginning of 2011.
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