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FDA: Xarelto not to be approved for acute coronary syndrome

Posted in Drug Studies, FDA Regulation, Public Health

Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention.

While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of stroke and blood clots in patients with an irregular heart beat that is not caused by heart problems”, due to a lack of data and a failure by the company to demonstrate the benefits of Xarelto outweigh the risk for bleeding associated with the drug, the FDA advisory panel decided that “Xarelto should not be approved to prevent further heart problems in patients who have recently suffered a heart attack”.

If the drug had been approved for acute coronary syndrome, it could be prescribed for “any condition brought on by a sudden, reduced blood flow to the heart, including heart attack and chest pain.”

Sadly, it seems Johnson and Johnson made its case based on evidence from only one research study.  Dr. Stephen Grant, consulting professor of medicine at Stanford University School of Medicine, gave an interview to Reuters, stating “Looking at the overall study it wasn’t robust enough in terms of statistical significance to be considered a positive study, and with that it was not possible to look at subgroups.”

“Dr. Stephen Grant, deputy director of the FDA’s division of cardiovascular and renal drugs, said the benefit of the drug met the criteria required to approve a drug based on a single trial – namely, proof it was superior in some way to existing products.”