Bayer Could Open New Market for Xarelto Drug After Successful Study

By Sonia Amaral Rohter Features Dow Jones Newswires

Bayer AG (BAYN.XE) on Sunday said that results of its phase III study of the blood thinner Xarelto showed that it lowered the combined risk of stroke, cardiovascular death and heart attack in patients with chronic coronary or peripheral artery disease by 24%.

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The new study could open a new market for coagulant Xarelto, which had 2.93 billion euros ($3.5 billion) in sales in 2016. The blockbuster anti-clotting drug is already approved to treat deep vein thrombosis and prevent blood clots in patients with atrial fibrillation, among other indications.

Xarelto, jointly developed by Bayer and Janssen Pharmaceuticals, is marketed outside the U.S. by Bayer and within the U.S. by Janssen, part of Johnson & Johnson.

The trial, which looked at the use of Xarelto combined with daily aspirin, ended ahead of schedule in February after interim analysis showed "overwhelming efficacy," according to Bayer. The study findings showed a 42% reduction of stroke and a 22% reduction in cardiovascular death. Bayer said the combination of Xarelto with daily aspirin demonstrated a 20% improvement in net clinical benefit, a measure of benefit-to-risk; in this case it was defined as the reduction in stroke, cardiovascular death, and heart attack balanced against major bleeding--internal bleeding that requires medical attention.

The company said the study showed that major bleeding rates were "low," despite recording an increased chance of this sort of serious bleeding.

More bleeding, a side effect of any blood thinner, has been a concern with Xarelto in the past. In 2012, the U.S. Food and Drug Administration advisory panel initially rejected an application to further expand the drug's indicated uses because of concerns about life-threatening bleeding.

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Cardiovascular disease is the leading cause of death globally, responsible for approximately 17.7 million deaths annually according to the World Health Organization.

Write to Sonia Amaral Rohter at sonia.amaralrohter@dowjones.com

(END) Dow Jones Newswires

August 28, 2017 10:55 ET (14:55 GMT)