J&J-Bayer’s Xarelto Fail to Win Expanded Use Approval

Johnson & Johnson and Bayer AG failed to gain U.S. approval to expand the use of the blood thinner Xarelto to prevent blood clots from developing on stents used in some heart-disease patients.

The Food and Drug Administration asked for more information about Xarelto’s use to reduce the risk of the dangerous clots in acute coronary syndrome patients. The company is confident in clinical trial results and is continuing talks with the FDA, Christopher Nessel, the cardiovascular franchise medical leader at J&J’s Janssen unit, said in a statement today.

Xarelto, the most-prescribed novel oral anticoagulant in the U.S., was approved in July 2011 to prevent blood clots in patients undergoing knee and hip surgeries and its use has since been expanded to patients with irregular heartbeats and deadly leg and lung blood clots. New Brunswick, New Jersey-based J&J owns rights to the medicine while Leverkusen, Germany-based Bayer sells the drug in Europe.

J&J declined less than 1 percent to $85.86 at 4 p.m. New York time. The shares have gained 28 percent in the past 12 months.

The new use sought by the companies was to treat stent thrombosis, where blood pools at the site of a stent typically used to keep arteries open. The condition can result in a heart attack or death. About 1.5 million people each year are implanted with coronary stents, J&J said.

Support Use

Data from the same trial referred to by Nessel also support the use of Xarelto to prevent heart attack and strokes in patients with acute coronary syndrome, which the FDA rejected in March. Xarelto was approved for the condition in the EU in May.

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.

Xarelto is one of the medicines being promoted 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.

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