US FDA advisory panel votes against added indication for Bayer's Xarelto

Despite relatively positive briefing papers earlier this week (The Pharma Letter May 22), the US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee yesterday voted six to four (with one abstention) against the approval of German drug major Bayer’s (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS).

The panel of experts said that Xarelto looked promising but missing data could skew results. They were also concerned about bleeding risks. "I want to see better evidence that this strategy of adding (Xarelto) ...is robustly better for the patient," commented Steven Nissen, a panel member and chairman of cardiovascular medicine at the Cleveland Clinic, adding: "And I just wasn't convinced."

"We appreciate the thoroughness of the Committee and, together with our cooperation partner Janssen Research & Development [a unit of US health care major Johnson & Johnson (NYSE: JNJ)], we will ensure that the questions raised today are addressed so the FDA may finalize their review," said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development.