Before the long weekend, the Food and Drug Administration approved Johnson & Johnson
The FDA gave Xarelto the OK to treat venous thromboembolism -- formation of blood clots -- in patients undergoing knee- and hip-replacement surgery. It'll have to compete with Sanofi's
There's also a generic version of Lovenox from Momenta Pharmaceuticals
The real potential for Xarelto lies in a heart-rhythm disorder called atrial fibrillation. The FDA is expected to rule on that indication in November.
The competition in atrial fibrillation isn't any easier, though. Doctors will be happy to ditch the current standard of care -- generic warfarin -- because it's really hard to find the proper dose, but Xarelto will run into new branded competition. Boehringer Ingelheim's Pradaxa is already on the market, and Pfizer
All three drugs are taken orally, but Xarelto has the advantage of once-a-day dosing, compared with twice-daily regimens for the other two. Whether that'll be enough to capture some of the atrial fibrillation market despite weaker data remains to be seen.
Of course, Johnson & Johnson and Bayer still need to get the drug approved for atrial fibrillation. Last week's nod should give investors a little confidence that the FDA considers Xarelto's risks manageable -- at least for one indication.
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