In a vote on Thursday, a U.S. Food and Drug Administration (FDA) panel again rejected expanding the approval for Johnson & Johnson’s blood thinner Xarelto (rivaroxaban). The drug maker had sought approval for Xarelto use in patients with acute coronary artery disease.
The FDA panel voted unanimously to reject wider use of Xarelto, saying J&J studies were missing too much information for the panel to accurately judge benefits and risks, Drug Discovery & Development magazine reports. Wider approval was denied in 2012 and twice since then the FDA has rejected J&J’s application. The panel’s vote is not binding but the FDA usually follows its panels’ recommendations.
Currently, Xarelto is approved to prevent blood clots for three groups: people with irregular heartbeats, people undergoing hip or knee replacement surgery, and people at risk of blood clots in the legs. FDA panel members expressed concern about bleeding risks with Xarelto and also had misgivings about the large number of patients who dropped out of company studies, according to Drug Discovery & Development. To address those concerns, J&J proposed limiting Xarelto use to 90 days, a time period for which the company has more data. But the FDA panelists said that even with a shorter time period, the data were not strong enough to support approval for wider use.
For patients taking Xarelto and other anticoagulant drugs, the major risk is unexpected or uncontrolled bleeding. Germany’s Federal Institute for Drugs and Medical Devices reported 968 cases of undesirable side-effects related to Xarelto in the first eights months of 2013, including 72 deaths, Der Spiegel magazine reported in September.
FDA panel member Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic, said, “Everybody, even the sponsor, would agree that this drug increases the risk of bleeding,” Drug Discovery and Development reports. And given the increased risk, “the quality of the data becomes increasingly important.”
