Panel recommends against Xarelto for ACS
FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6-4, with one abstention, against recommending approval of 2.5 mg twice-daily Xarelto rivaroxaban from Johnson & Johnson (NYSE:JNJ) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS), non-ST-elevation myocardial infarction or unstable angina. The panel found Xarelto's efficacy data to be underwhelming in light of concerns about an increased risk of bleeding. Members also were concerned about the statistical design of the Phase III trial as well as the large number of patients who withdrew consent and were not included in follow-up analyses. The sNDA has Priority Review, with a June 29 PDUFA date.
In FDA's briefing documents released on Monday, an agency reviewer recommended in favor of approval, albeit with various contraindications and the addition of new information about the risk of bleeding to a boxed warning on Xarelto's label (see BioCentury Extra, May 21). ...