Bayer, J&J anticoagulant filed for U.S. approval

LONDON (Reuters) - Bayer AG's (BAYG.DE) key new anticoagulant drug Xarelto has been submitted for approval in the United States by its partner Johnson & Johnson (JNJ.N).

The German drugs and chemicals group also announced on Wednesday that clinical trials involving 7,000 patients showed there were no issues attributable to the drug, also known as rivaroxaban, after long-term exposure.

Bayer estimates eventual global peak sales of Xarelto, which won a positive recommendation from the European Medicines Agency last week, could reach 2 billion euros ($3.15 billion) for all indications.

Although the initial use of Xarelto will be in preventing blood clots after hip- and knee-replacement surgery, the big commercial potential lies in using it to prevent strokes in people with atrial fibrillation, a common heart arrhythmia.

To win big take-up in the stroke prevention indication, where patients will take the medication on a long-term basis, the drug needs to have no serious side effects -- and so far the safety data looks good.

Bayer said no safety issues attributable to Xarelto had been seen in around 7,000 patients taking the drug for at least three months of which approximately 4,500 were treated for six to 12 months or longer.

The medicine is taken as a single tablet, once daily.

It will compete in the surgical setting with Sanofi-Aventis SA's (SASY.PA) top-selling injectable drug Lovenox, which is currently the standard treatment given to patients after major orthopaedic operations. Worldwide sales of Lovenox totalled 2.6 billion euros in 2007.

It also faces a newer competitor in the form of Boehringer Ingelheim's blood clot drug Pradaxa, which was approved in Europe in March.

(Reporting by Ben Hirschler; editing by Sue Thomas)