Bayer gets EU approval for anticlotting medicine

Bayer HealthCare, a division of the German drug, chemical and agricultural products maker Bayer AG, said the product will be launched soon in the European Union, which includes 27 countries. The company, which is jointly developing the drug with Johnson & Johnson, recently launched Xarelto in Canada, where it got its first approval on Sept. 15.

Xarelto, a once-daily pill known chemically as rivaroxaban, is one of several new anticlotting drugs, most still in development, that work through different mechanisms than older treatments and are meant to be more effective and safer. A mainstay of anticlotting treatment called Coumadin or warfarin, for example, can interact with many drugs and requires patients to undergo frequent blood tests because a two-high or too-low dose can lead to strokes or dangerous excessive bleeding, respectively.

Companies developing new types of anticlotting drugs include Eli Lilly & Co., Momenta Pharmaceuticals Inc. and partners Pfizer Inc. and Bristol-Myers Squibb Co., which markets the blockbuster anticlotting drug Plavix.

Xarelto is awaiting approval in the United States and more than 10 other countries for use in preventing blood clots in patients having planned, or elective, surgery to replace a hip or knee, Bayer said.

Bayer HealthCare, based in Leverkusen, Germany, said its drug has been tested in nearly 10,000 people and the company is running studies involving tens of thousands more patients worldwide. Those are aimed at getting approval for using the drug to prevent and treat both acute and chronic blood-clotting disorders, including preventing blood clots in leg or other large veins, heart attacks in people who already have had one and strokes in patients with a certain abnormal heart rhythm.

"Xarelto could prove to be a significant medical breakthrough, Bayer AG Chief Executive Officer Werner Wenning said in a statement. "As Xarelto has the potential to become a blockbuster, its launch is an important milestone for Bayer."

Life-threatening blood clots kill roughly 1.5 million people in the United States and European Union each year, including hundreds of thousands of people getting hip or knee replacement surgery, so these new drugs have a significant market likely to grow as the population ages.