June 25, 2012 — The Janssen unit of Johnson & Johnson sought expanded approval of Xarelto for patients with Acute Coronary Syndrome, which would have increased their potential market by millions of patients. The FDA rejected the application, citing concerns over severe bleeding and large amounts of missing data in the ATLAS safety study. Xarelto (rivaroxaban) is a new type of blood-thinner competing with Pradaxa (dabigatran) and Coumadin (warfarin) for dominance in a multi-billion market for anti-clotting drugs to prevent strokes, blood clots, and heart attacks.
In May of 2012, an FDA advisory committee voted 6-4 to reject the expanded approval of Xarelto in patients with ACS. They were primarily concerned about the risk of bleeding, but also concerned about incomplete safety data in the ATLAS clinical trial, which was the foundational safety study conducted by Janssen.
All blood-thinners carry a risk of bleeding. For 50 years, most patients who need to take a blood-thinner have been given Coumadin (warfarin), which has a notoriously high risk of bleeding, but can be reversed with a dose of Vitamin K. In the event of a life-threatening emergency, it is essential that a physician stop the anti-clotting effects of a blood-thinner to stop bleeding. Unfortunately, Xarelto has no easy reversal mechanism.
The FDA was concerned that the incidence of severe, life-threatening bleeding events would increase if they expanded approval of Xarelto to ACS patients.
The FDA was also concerned about serious flaws in the ATLAS safety study. The final results of the study showed that Xarelto plus warfarin reduced the risk of heart attack, stroke, and cardiovascular death when compared to warfarin alone. While this is a good result, the FDA was concerned that they study lacked follow-up data on 2,400 patients who dropped out of the study. The final results also failed to include the deaths of several patients involved in the study.
Acute Coronary Syndrome is a cardiovascular disorder that occurs when a patients suffers sudden, decreased blood flow to the heart muscle. It is usually caused by plaques made of fat deposits that develop in the arteries leading to the heart. People who have ACS have a higher risk of blood clots, heart attack, and stroke, which is why many take a blood-thinning medication.
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