Posted on 02/09/2010 in Pharmaceutical Company Product News Boehringer Ingelheim has been granted priority review status by a key healthcare regulator for dabigatran etexilate, its innovative new treatment for atrial fibrillation sufferers.
The US Food and Drug Administration (FDA) has given the designation for the novel oral direct thrombin inhibitor, which is intended to help prevent strokes, based on positive data from the recent RE-LY clinical trial.
This decision recognises the fact that dabigatran etexilate represents a significant advance in an area where no comparably adequate therapy exists.
Registration submissions for the drug are also ongoing in Europe, Japan and other territories, with Boehringer Ingelheim expecting the first approval of the treatment to be issued later this year or in early 2011.
Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "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."
This comes in the same month that the company, which was founded in 1885, marks its 125th anniversary. Other news stories from 02/09/2010
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