J&J, Bayer Fail to Win Expanded U.S. Backing for Xarelto
This article is for subscribers only.
Johnson & Johnson and Bayer AG failed to gain U.S. approval to expand the use of their blood thinner Xarelto to prevent heart attacks and strokes in patients with serious chest pain or a previous heart attack.
The Food and Drug Administration declined to clear the treatment for acute coronary syndrome in a complete response letter, New Brunswick, New Jersey-based J&J said yesterday in a statement. FDA advisers voted to recommend against approval May 23 because of missing data from 1,000 patients who withdrew from a late-stage trial of the drug.