FDA Panel Backs New Anti-Clotting Drug

THURSDAY, March 19 (HealthDay News) -- The benefits of the experimental blood-thinning drug rivaroxaban outweigh its risks, a U.S. Food and Drug Administration advisory panel said Thursday.

Rivaroxaban (Xarelto) could be one of the long-sought alternatives to commonly used blood thinners, particularly for hip- and knee-replacement patients.

The panel voted 15 to 2 in favor of the Johnson & Johnson product, despite risks of internal bleeding associated with it. Although the FDA is not bound by its advisory panels' recommendations, it typically follows them.

The drug was more effective at reducing potentially fatal blood clots than heparin, a widely used blood thinner, with no increase in side effects, according to studies by three research teams, whose papers were published in June in the New England Journal of Medicine and The Lancet.

Heparin is commonly used in hospitals, because it is easier to manage than Coumadin (warfarin), which requires frequent blood tests for close control. Rivaroxaban is a pill that does not require constant monitoring.

Johnson & Johnson and its partner Bayer are asking the FDA to approve rivaroxaban for use in patients who have had hip or knee replacements. The once-a-day pill could prevent clots from forming and traveling to the lungs. Clots are a common side effect after these replacement procedures.

The FDA is scheduled to make a decision on rivaroxaban by May 28, according to the Associated Press. If approved, the drug would be the first oral anticoagulant drug approved since the FDA approved warfarin in 1954, according to Dow Jones.

Johnson & Johnson reacted positively to the panel's recommendation.

"We appreciate the thoroughness of the advisory committee's review, and we will continue to work with the FDA as they finalize their review," Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

SOURCES: March 19, 2009, news release, Johnson & Johnson; Associated Press; Dow Jones

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