FDA denies approval to expanded use of J&J/Bayer’s Xarelto

(Reuters) – Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome. The drug, which J&J has developed in partnership with German drugmaker Bayer AG, was earlier denied approval in June for the same use, as a panel to the U.S. Food and Drug Administration raised concerns about missing trial data and bleeding risks. …