US FDA gives priority review to Boehringer Ingelheim's AF drug dabigatran etexilate

Independent German drug major Boehringer Ingelheim says that the US Food and Drug Administration has granted a priority review designation for its novel oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke in atrial fibrillation (AF) patients. An FDA advisory committee will meet on September 20 to review and discuss dabigatran etexilate data.

In addition to the USA, the registration process for dabigatran etexilate is underway in Europe, Japan and other countries. The company expects to receive marketing authorization for the drug in first countries by end of 2010 or beginning of 2011.

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