Janssen Research & Development, said Wednesday the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for Xarelto (rivaroxaban).
The new designation include a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy. This made Xarelto the only NOAC to show superiority over aspirin with comparable rates of major bleeding, the company noted.
VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), and pulmonary embolism (PE), a clot that travels to the lung.i Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years.
“The FDA’s acceptance of our sNDA for priority review marks another important step toward a potential shift in how people with VTE are managed over time,” said Paul Burton, Vice President, Medical Affairs, Janssen. “We are pleased the FDA sees the urgency in offering the choice of a 10 mg dose of Xarelto or the currently approved 20mg dose. This will broaden the physician’s ability to customize treatment plans based on the needs of each patient.”