FDA staffers basically back Xarelto for ACS but identify missing data in study

The US Food and Drug Administration advisory panelists due to revue Johnson & Johnson (NYSE: JNJ) and Bayer’s (BAYN: DE) New Drug Application for their anticoagulant Xarelto (rivaroxaban) on Wednesday, have been issued with FDA staff briefing documents indicating that the drug should be cleared for the prevention of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

Xarelto is already approved for reduction of the risk of blood clots in the legs and lungs of people who have had knee or hip replacement surgery, as well as the prevention of strokes among people with irregular heartbeats, called atrial fibrillation. Now the companies are seeking approval for reducing the risk of stroke and heart attack in people with acute coronary syndrome.

However, the briefing documents noted that RIVAROXACS301, the ATLAS ACS trial, had substantial missing data, noting that poor follow-up, predominantly attributed to withdrawal of consent, has been a distressing trend in recent cardiovascular outcomes trials.