Boehringer wins blockbuster Pradaxa approval

Boehringer Ingelheim has won a heated race for approval of a new blood thinner, gaining a regulatory OK from the FDA for a drug that is expected to earn blockbuster revenue as the anticlotting market in the U.S. grows to $12 billion a year. Pradaxa is now approved to prevent strokes in patients with an irregular heartbeat.

The new thrombin inhibitor helps rein in an enzyme that plays a key role in blood clotting. Boehringer took the drug through a rigorous trial process, which included comparing the therapy to the longtime standard warfarin. Norman Stockbridge, the director of the FDA's cardiovascular and renal products division, notes that Pradaxa has been shown to be superior to warfarin, making periodic monitoring of patients unnecessary.

As Dow Jones notes, Barclays has estimated that the anticlotting drug market will grow to $12 billion over the next year. Sanford C. Bernstein, meanwhile, believes that Pradaxa can garner $4 billion a year. That kind of money has attracted a host of potential competitors, with Bayer teaming with J&J on rivaroxaban--sold in Europe as Xarelto but still in front of the FDA--with BMS and Pfizer collaborating on pixaban while Merck and Portola are working on betrixaban.

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