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01-06-2012 00:14:00

UK Regulator Draft Guidance Recommends Bayer's Xarelto For Blood Clots

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FDA NEWS RELEASE For Immediate Release: Dec. 4, 2013 Me..

FRANKFURT -(Dow Jones)- The U.K. drug regulator has recommended the use of Xarelto, a drug produced by a unit of Bayer AG (BAYN.XE), to treat blood clots, according to draft final guidance published Friday.

The guidance is likely to result in a recommendation from the National Institute for Health and Clinical Excellence, known as NICE, meaning the U.K. public health-care system will offer the drug and pay for it. The draft guidance is now with consultees, who have the opportunity to appeal against it.

"Bayer Healthcare welcomes this draft final appraisal determination recommendation from NICE because it simplifies the treatment of venous blood clot treatment for physicians and their patients," Bayer spokeswoman Astrid Kranz said.

Earlier, NICE had asked Bayer to provide more information on the drug. The move follows a May 22 approval for Xarelto for stroke prevention and systemic embolism in people with atrial fibrillation.

If the final approval is given, Xarelto, also known as Rivaroxaban, may then be offered as an alternative to injectable anticoagulants such as low-molecular-weight heparin or fondaparinux sodium, overlapped with a vitamin-K antagonist, such as warfarin.

It is estimated that there will be over 46,000 cases of acute deep vein thrombosis, or DVT, in England and Wales during 2012, rising to nearly 50,000 by 2016 due in large part to the aging population, NICE said.

"Xarelto is the first only novel oral anticoagulant offering a unique single drug solution for the treatment of DVT in adults," Kranz said.

On May 24, Bayer confirmed it expects peak sales of Xarelto of above EUR2 billion annually. The drug, which is being co-developed by Bayer and U.S. drug maker Johnson & Johnson (JNJ), is a rival of Boehringer Ingelheim GmbH's Pradaxa.

-By Monica Houston-Waesch, Dow Jones Newswires; +49 69 29 725 504; nikki.houston@dowjones.com

(END) Dow Jones Newswires

May 31, 2012 18:14 ET (22:14 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

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