Xarelto tees up big new European approval

Bayer's ($BAY) new anticoagulant drug Xarelto won a crucial recommendation for European approval for the prevention of stroke in patients with atrial fibrillation. The drug was already approved to prevent clotting in patients undergoing hip replacement surgery, but the stroke-prevention market is vastly larger. And if Xarelto wants to be a blockbuster, it will have to capture a share of that.

The European market is especially key for Bayer's sales of Xarelto, Reuters notes. Its partner Johnson & Johnson ($JNJ) gets 70% of any sales in the U.S. market. The German company has said it expects Xarelto to bring in $2.7 billion in annual sales. The new European recommendation also includes a new indication for deep vein thrombosis (DVT) treatment and prevention.

Xarelto is one of several new players that will be jockeying for position in the bloodthinner market. Designed to be alternatives to the longtime standard treatment warfarin, the oral meds include Pradaxa, a Boehringer Ingelheim drug already approved in Europe for the stroke-prevention use, and Eliquis, the Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) drug awaiting approval in Europe and the U.S.

The global market for these oral warfarin alternatives is expected to grow to $20 billion. Pradaxa has the first-to-market advantage, but some analysts believe Xarelto can quickly establish itself as an easier-to-use rival that may also carry fewer side effects. Xarelto is a once-a-day drug, whereas Pradaxa is administered twice daily. But at least in the U.S., Xarelto may not be deemed superior to warfarin, but only "non-inferior" to the older drug. Eliquis could well qualify for a superiority claim, giving it a big advantage over the other two.

"Given that Pradaxa has only just been launched in Europe for atrial fibrillation and does not have the DVT indications, but does have a warning on increased heart attack risk, we believe Xarelto will have a very competitive profile in Europe," Maxwell Craig of UniCredit told the Wall Street Journal. "Eliquis looks to be the key competitor, but will be around 10 months behind Xarelto and will not have the DVT indication at launch."

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