EMA: Faulty device didn't distort study findings for Bayer's Xarelto

Last December, European regulators said they were no longer sure whether results from a trial of Bayer's new-age clot-buster Xarelto were accurate thanks to a defect in a blood-clotting testing device used in the study. But the German pharma can breathe easy now.

Friday, the European Medicines Agency said that the device--an INR product from Alere ($ALR), recalled in December--did not distort the main findings of the study, which established Xarelto's superiority over old-guard therapy warfarin as a treatment for atrial fibrillation.

"Xarelto can continue to be used as before, in line with the current prescribing information," the agency said on its website.

It's good news for Bayer, which counts Xarelto among 5 new products slated to bring in the bulk of its growth going forward. At the end of October, the med boasted a 34% market share around the world, Reuters reports, and it raked in €1.6 billion for the German pharma--which shares it with Johnson & Johnson ($JNJ)--through the first 9 months of last year.

And while Xarelto's makers are hard at work on clinical trials that could bring in new indications, atrial fibrillation is currently its largest market--and there, it competes with Boehringer Ingelheim's Pradaxa and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis.

So far in its lifespan, Xarelto hasn't had any problem climbing its way to the top of its class--and staying there. But new developments for its rivals could mean more serious competition. Last October, the FDA approved Praxbind, a reversal agent for Boehringer's med, making it the only next-gen anticoagulant whose effects can be reversed in the event of profuse bleeding.

And last week, Bristol-Myers execs told shareholders that Eliquis is now No.1 in new-to-brand patient share in cardiology in 12 markets around the world, predicting that the therapy was "well on our way" to becoming the top dog worldwide.

- read the EMA's statement
- get more from Reuters

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