Drug approval processes: A case study of rivaroxaban

Abstract

Rivaroxaban, a Xa inhibitor, was recently approved (March 2013) in the setting of post-acute coronary syndromes (ACS) by the European Medicine Agency. This is in contrast to not being approved by the Food and Drug Agency in the United States for the same indication in 2012 and 2013. The FDA′s decision was based on a lack of follow-up data for the patients enrolled in the study based on the pivotal Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome (ATLAS-ACS 2-TIMI 51) trial. While both agencies have similar roles when functioning as drug regulatory bodies and goal of granting approval of safe and efficacious drugs, the difference in approval outcome in the case of rivaroxaban highlights the differences in drug review process when both agencies are presented with the same Phase 3 data to review.

Keywords

• Drug approval process
• European medicines agency
• food and drug administration
• rivaroxaban