WASHINGTON – A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson’s blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.
The FDA panel on Thursday voted unanimously against broader use of the pill, saying too much information is missing from company studies to accurately gauge Xarelto’s benefit. The same panel also voted against broader approval in 2012.
The FDA, which is not required to follow the panel’s advice, has also twice rejected J&J’s request to approve Xarelto for preventing life-threatening blood clots in patients with acute coronary artery disease.
J&J already markets the pill for several patient groups, including those with an irregular heartbeat and those undergoing hip or knee replacement surgery.