UPDATE 1-U.S. FDA rejects wider use of Xarelto drug
NEW YORK, Feb 14 (Reuters) - U.S. health regulators have declined to approve proposed wider uses of Bayer AG and Johnson & Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday.
The companies had sought approval from the U.S. Food and Drug Administration (FDA) to market the blockbuster pill for prevention of new heart attacks and strokes, and death, in patients with heart disease, and also to prevent clogging of heart stents.
Xarelto's biggest current approved use is to prevent blood clots and strokes in patients with an irregular heartbeat called atrial fibrillation. The condition occurs mainly in the elderly.
An advisory panel to the FDA concluded in January that Xarelto should not be approved to prevent new heart attacks or strokes, a use referred to as secondary prevention. The medicine is co-marketed by J&J and Bayer.
Johnson & Johnson spokeswoman Kristina Chang declined to comment when asked if the FDA, in its rejection, had asked for new clinical trials to be conducted for the requested new uses or asked for other information.
"We are not disclosing the details because we still are evaluating the contents and our next steps," Chang said.
Shares of J&J were up 0.3 percent in premarket trading, while shares of Bayer rose 0.71 percent in Germany.