* EU Approval cements Boehringer lead in promising drug class
* Bayer, J&J had requested U.S., EU approval in Jan
(Adds details, background)
FRANKFURT, Aug 4 Boehringer Ingelheim won European clearance for its stroke prevention pill Pradaxa, defending its lead over Bayer (BAYGn.DE) and Bristol Myers (BMY.N) in one of the most promising new classes of medicine.
The EU commission cleared the 150mg dose for most patients, while the 110mg dose will be available for patients aged 80 years or above and certain risks groups, the unlisted German drugmaker said on Thursday.
Pradaxa, which has been on the U.S. market since late last year, is one of three new anti-blood-clotting pills expected to replace the decades-old, and potentially dangerous, stroke preventer warfarin. Analysts estimate the total annual market for such oral drugs as high as $20 billion.
Bristol-Myers Squibb and partner Pfizer (PFE.N) said in June that their experimental drug, apixaban, proved superior and far safer than warfarin in preventing strokes in patients with dangerously irregular heart rhythms.
Based on the stellar stroke prevention data, Bristol and Pfizer said at the time they plan to seek approval for apixaban, branded as Eliquis, in the third or fourth quarter of 2011 for that use.
Bayer and development partner Johnson & Johnson (JNJ.N), filed in January for U.S. and European approval of its Xarelto pill, based on the active ingredient rivaroxaban, for stroke prevention.
(Reporting by Ludwig Burger)
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