Company news: Auxilium and GSK; J&J's Janssen
J&J's blood thinner Xarelto (Rivaroxaban) is up for review by an FDA advisory panel Wednesday. The drugmaker's Janssen unit is looking to expand the drug's indication for use among patients with acute coronary artery disease. It is approved to prevent deep vein thrombosis and to reduce stroke risk for patients with nonvalvular atrial fibrillation. Preview documents show that board is divided and skeptical about the patient pool, reported Reuters. Among the concerns: that J&J excluded three patients from the headcount even though they'd died during the study, and that it puts patients at an elevated risk for bleeding. Reuters notes that the panel's clinical reviewer stood up for the data and said J&J saw data was missing and tried to fix things.