Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle

FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.