J&J has scored another big regulatory win, gaining FDA approval late on Friday for Xarelto, a blood clot prevention therapy that has been tapped as one of the drug company's top six new drugs for the U.S. market. The FDA's approval marks the first time an oral treatment has been approved to prevent VTE--venous thromboembolism--in joint replacement surgeries and points the way to the much broader use of the anticoagulant.
The company, which co-developed the drug with Bayer, has been working for the past two years to resolve questions raised by the FDA. Xarelto has been available in Europe since 2008. It's been one of a slate of new drugs that aim to gain market share from warfarin, a much older and problematic generic treatment. And J&J is hoping to follow up relatively quickly with another regulatory approval to use Xarelto to prevent strokes in patients suffering from atrial fibrillation.
Warfarin-replacing therapies could earn more than $20 billion a year, according to some analysts, making this one of the most lucrative new drug markets to shoot for.
J&J's tardy win at the FDA still puts the company ahead of Pfizer, which has been in the hunt for an approval of its own Factor Xa inhibitor, apixaban. The two companies have been sparring in the clinic as J&J has tried to distinguish Xarelto as a preferable once-daily therapy with potentially better data--though that case has yet to be closed. Apixaban is dosed twice daily but has also demonstrated solid efficacy results in clinical trials.
"Xarelto has a proven clinical benefit over one of today's most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice," said Louis M. Kwong, M.D., a professor at Harbor-UCLA Medical Center.
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- here's the story from Dow Jones