FDA Rejects Wider Use of Xarelto
By Reuters Staff
NEW YORK - U.S. health regulators have declined to approve proposed wider uses of Bayer AG and Johnson & Johnson's anticoagulant Xarelto (rivaroxaban), the drugmakers said on Friday.
The companies had sought approval from the U.S. Food and Drug Administration (FDA) to market the drug for prevention of new heart attacks and strokes, and death, in patients with heart disease, and also to prevent clogging of heart stents.
Xarelto is already FDA-approved for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for preventing recurrences; for reducing the risk of DVT and PE after knee- or hip-replacement surgery; and for cutting the risk of stroke in patients with nonvalvular atrial fibrillation.
An advisory panel to the FDA concluded in January that Xarelto should not be approved as secondary prevention for further heart problems in patients who have had heart attack or stroke.
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.
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