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Boehringer's Pradaxa wins US approval

The US Food and Drug Administration has approved Boehringer Ingelheim's Pradaxa – the first new oral anticoagulant approved in the US for 50 years

The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim's Pradaxa (dabigatran etexilate) to reduce the risk of stroke and blood clots in patients with atrial fibrillation (AF), making the product the first new oral anticoagulant approved in the US in more than 50 years.

Pradaxa, which is taken twice daily, was shown in the company's 18,113-patient phase III clinical trial to reduce stroke and systemic embolism by 35 per cent beyond the reduction achieved with warfarin, which was approved in the 1950s and remains the current standard of care. The study was the largest stroke prevention trial in AF patients ever completed.

In addition to being more effective than warfarin, Pradaxa has the advantage of not requiring the blood monitoring or dietary restrictions that are necessary with the older drug. Warfarin is sold under a number of brand names, including Bristol-Myers Squibb's Coumadin and Upsher-Smith's Jantoven.

AF, which is characterised by irregular heart rhythm and affects about 2.3 million people in the US, can cause blood clots that lead to stroke. Strokes associated with AF can be about twice as likely to be fatal or severely disabling as non-AF strokes, according to Boehringer.

Pradaxa is an anticoagulant that inhibits thrombin, an enzyme involved in blood clotting. The drug must be sold with an FDA-approved Medication Guide that informs patients that, like other anti-clotting drugs, it carries the risk of serious bleeding. Patients will be given the guide each time they fill their prescription.

Pradaxa could generate sales of $1.3bn by 2018 in the US, France, Germany, Italy, Spain, the UK and Japan, according to the research firm Decision Resources. The drug is likely to have significant competition from Bayer's novel anticoagulant Xarelto, which is already cleared for marketing in the EU and is currently under review by the FDA.

21st October 2010

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