ATLAS Trial Design Blamed For Missing Data On Xarelto ACS Use

Elements of the ATLAS clinical trial’s protocol and design may have undermined the quality and amount of data supporting use of Johnson & Johnson/Bayer HealthCare AG’s Xarelto (rivaroxaban) for acute coronary syndromes, members of FDA’s Cardiovascular and Renal Drugs Advisory Committee said.

During their May 23 review of an ACS indication, panelists questioned whether the sponsors could have done more to prevent a high percentage of patients from withdrawing consent in the...