J&J, Bayer Fail to Win U.S. Backing for Expanded Xarelto

Johnson & Johnson (JNJ) and Bayer AG (BAYN) failed to win approval to expand use of their blood thinner Xarelto to prevent heart attacks and strokes in patients with serious chest pain or history of cardiac illness.

The Food and Drug Administration raised questions about Xarelto’s use in reducing the risks for patients with acute coronary syndrome, Johnson & Johnson said in a statement. Xarelto was approved in July 2011 to prevent blood clots in patients undergoing knee and hip surgeries and its use has since been expanded patients with irregular heartbeats and deadly leg and lung blood clots.

Acute coronary syndrome is an umbrella term for situations when the blood supplied to the heart is blocked, according to the American Heart Association. The condition leads to 1.2 million hospitalizations each year. AstraZeneca Plc (AZN)’s Brilinta and Eli Lilly & Co. (LLY)’s Effient have already been on the market as a treatment for acute coronary syndrome.

The FDA last year had rejected the expanded use application by New Brunswick, New Jersey-based J&J and Leverkusen, Germany- based Bayer. Agency advisers who had recommended against approval in May, cited missing data from 1,000 patients who withdrew from a late-stage trial of the drug.

J&J owns rights to the medicine while Bayer sells the drug in Europe.

Xarelto is one of the medicines attempting to replace warfarin, a more than 50-year-old drug that requires constant monitoring and dose adjustments to keep blood from getting too thin and putting patients at risk of severe bleeding.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

http://www.bloomberg.com/news/2013-03-05/j-j-bayer-fail-to-win-u-s-backing-for-expanded-xarelto-use.html?