FDA panel again rejects wider use of J&J's Xarelto

WASHINGTON, D.C.; Janaury 16, 2014

The application was to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.

The condition occurs when narrowed blood vessels restrict blood flow to the heart, increasing the risk of heart attack and other potentially deadly problems.

The FDA panel on Thursday voted unanimously against the broader use of the pill, saying too much information is missing from company studies to accurately gauge Xarelto's benefit. The same panel also voted against wider approval in 2012. The FDA has twice rejected J&J's application since then. The agency is not required to follow the panel's advice, though it often does.

J&J already markets the pill for three patient groups: Those with irregular heartbeats, those undergoing hip or knee replacement surgery, and those at risk of blood clots in the legs.

FDA panelists expressed concern about bleeding side effects linked to the pill and the large number of patients who dropped out of company studies. J&J attempted to address those concerns by proposing that patients only use Xarelto for 90 days, a relatively short time period for which the company has more data. But even for that timeframe, FDA panelists said that there was too much missing information to consider approving the drug, given its safety risks.

"Everybody, even the sponsor, would agree that this drug increases the risk of bleeding," said Dr. Steven Nissen, an FDA panelist and chairman of cardiology at the Cleveland Clinic. "And in that context the quality of the data becomes increasingly important."

J&J Vice President Paul Burton said in a statement that the company "will work with the FDA to address questions raised today."

Xarelto sales last fall hit $246 million.

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