FDA Panel Rejects Broader Use of J&J's Xarelto (Again)
A panel of FDA experts again rejected Johnson & Johnson's application to expand use of its blood thinner, Xarelto, to reduce dangerous blood clots in a new group of patients -- those with acute coronary artery disease.
J&J already markets Xarelto to three groups: patients with irregular heartbeats, patients undergoing hip or knee replacement surgery, and patients at risk of blood clots in the legs.
The FDA panel voted unanimously against the broader use of the pill, however, again saying too much information is missing from company studies to accurately gauge Xarelto's benefits and associated safety risks.
The FDA had previously rejected the drug for wider use in January 2012, also citing missing clinical-trial data and bleeding risks. The application was rejected again in May and June 2012.