Disappointing FDA views for Bayer's Xarelto and Pozen ulcer drug

Bayer HealthCare, a unit of Germany’s Bayer (BAYN: DE) says that it has received a complete response letter from the US Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto (rivaroxaban) in combination with standard antiplatelet therapy for the reduction of secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with acute coronary syndrome (ACS).

Bayer says it is evaluating the FDA’s letter together with its partner Janssen Research & Development, a Johnson & Johnson (NYSE JNJ) subsidiary, and will respond to the Agency's questions. On May 23, 2012, Last month, the FDA's Cardiovascular and Renal Drugs Advisory Committee narrowly voted (six to four with one abstention) against recommending approval of rivaroxaban in this indication (The Pharma Letter May 24). Bayer did not give any details of what further data or action the FDA has requested.

The panel of experts said that Xarelto looked promising but missing data could skew results, and also expressed concerns 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."