FDA Panel Does Not Recommend New ACS Indication for Xarelto
June 22, 2012 — The the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee voted in May against recommending approval of expanding the indication for rivaroxaban (Xarelto). The drug’s maker, Janssen Research and Development LLC, wants to expand the indication to include the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). The FDA recently issued a response letter regarding the drug’s supplemental new drug application (sNDA), which the company is evaluating and said it will address the agency's questions.
Xarelto is approved for three clinical uses in the United States: To reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, to reduce this risk in people who have just had hip replacement surgery and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem. Janssen submitted this sNDA in December 2011 and received a priority review designation from the FDA in February.
Healthcare market research firm Decision Resources recently surveyed U.S. cardiologists and managed care organization (MCO) pharmacy directors. Respondents said reducing the incidence of mortality is the greatest unmet need in post-myocardial infarction and Xarelto is being watched as a possible pharmaceutical solution.
“Despite the declining rate of deaths due to myocardial infarction and despite the emergence of novel antiplatelet agents and optimal statin therapy, the incidence of mortality remains the attribute that most influences surveyed cardiologists’ prescribing decisions in post-myocardial infarction,” said Decision Resources analyst Conor Walsh, Ph.D. “According to clinical data and thought leaders we interviewed, Bayer/Janssen’s Xarelto has demonstrated the potential to significantly fulfill this unmet need.”
For more information: www.janssenrnd.com