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Sanofi withdraws two treatments

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Sanofi-Aventis has withdrawn applications in Europe and the US for eplivanserin, an insomnia treatment, because it needs “significant further clinical development”.

It is also discontinuing idrabiotaparinux, used to prevent clots in patients with atrial fibrillation, after “recent therapeutic advances in the field”.

Those include promising results for Boehringer Ingelheim’s rival Pradaxa, which has been found to prevent more strokes and clots than warfarin, a generic blood thinner.

Meanwhile, Sanofi says that the US Food and Drug Administration (FDA) has granted an accelerated review of its cabazitaxel as a second-line treatment for prostate cancer.

In September the FDA rejected eplivanserin, also known as Ciltyri, saying additional information about its benefits and risks would be needed before approval.

And Europe regulators have recommended a combination of the French drugmaker’s Plavix blood-thinner and aspirin to prevent clots caused by plaque build-up in the arteries.

Copyright Press Association 2009



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