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FDA Panel Recommends Approval of Johnson & Johnson Anti-Clot Drug

Mar 20, 2009 | Parker Waichman LLP

Earlier this week we reported that U.S. Food and Drug Administration (FDA) staffers criticized a proposed new blood thinner called rivaroxaban, according to a Dow Jones report.  Now, says HealthDay News, the FDA’s advisory panel found that rivaroxaban’s benefits outweigh its risks, opening the door for FDA approval of the controversial drug.

The anti-coagulant rivaroxaban was created to prevent blood clots from forming and, while better than some of its competition at such prevention, said Dow Jones earlier this week, the medication was found to increase bleeding in patients in clinical studies, the FDA revealed.  Regardless, the panel voted 15-to-2 in favor of the drug, made by Johnson & Johnson (J&J) as part of a joint venture with Bayer AG’s health care unit, said HealthDay News, which noted that while the FDA is not required to follow its advisory’s findings, it generally does.

Rivaroxaban is sold in Europe under the brand name Xarelto and was approved there last year.  The pharmaceutical companies had been awaiting FDA approval for short-term use in blood clot prevention following hip- or knee-replacement surgery.  Blood clots can be fatal if they travel to the lungs, heart, or brain and typically form in the legs, Dow Jones explained in its earlier report.  Dow Jones noted that no oral blood thinner has been approved by the FDA since warfarin in 1954; the FDA is scheduled to make its decision by May 28, according to the Associated Press, said HealthDay News.

Proponents of rivaroxaban claim it offers blood-clotting benefits over the more commonly used blood thinner, Heparin, said HealthDay News.  Heparin is typically used in hospital environments because it’s easier to monitor than Coumadin (generic:  warfarin), which—said HealthDay News—requires ongoing blood tests to manage blood levels; rivaroxaban is administered as a once-a-day pill.

According to an earlier report by Reuters, FDA staff found that bleeding, cardiovascular events, and potential liver injury were linked to the anti-coagulant; its brand-name European version—Xarelto was found to cause bleeding “in significantly more patients” than enoxaparin, the current treatment used in the U.S. Enoxaparin is sold by Sanofi-Aventis SA under the brand name Lovenox. The clinical review stated that long-term safety data is needed to adequately evaluate rivaroxaban’s liver damage potential, said Reuters, which results from an increase in a liver enzyme that is indicative of liver damage, said Dow Jones.

Data submitted to the FDA concerning the drug included four major clinical studies involving over 12,000 patients, said Dow Jones; the studies typically compared rivaroxaban to enoxaparin and revealed that bleeding which required medical intercession, while low, occurred at twice the rate as enoxaparin, a significant finding. The FDA found that in addition to bleeding risks being higher in the rivaroxaban group over the enoxaparin group, two rivaroxaban patients died of a fatal bleed during the clinical trial, said Dow Jones this week. There were no deaths in the enoxaparin group.

Rivaroxaban differs from other anti-coagulants—Bristol-Myers Squibb Company’s and Sanofi Aventis SA’s Plavix and aspirin—because existing treatments ensure blood platelets do not stick together said Dow Jones, whereas rivaroxaban targets Factor Xa, an enzyme involved in blood-clotting.

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