J&J Submits Revised New Drug Application for Artery Disease Drug
Johnson & Johnson has submitted a supplemental New Drug Application to the FDA seeking approval for Xarelto (rivaroxaban) plus aspirin for patients suffering from peripheral artery disease (PAD).
The new indication for the drug combination would be for reducing the risk of heart attack, stroke and amputation after blood flow is restored to the legs and feet following complications from PAD.
The application is supported by data showing that Xarelto plus aspirin reduced the risk of major cardiovascular and limb adverse events.
The combination was first approved by the FDA in 2018 for reducing the risk of major cardiovascular events in PAD and coronary artery disease patients. PAD affects an estimated 20 million people in the U.S.