US regulators have approved Bayer/Janssen’s Xarelto to cut the risk of major cardiovascular (CV) events in people with chronic coronary or peripheral artery disease (CAD/PAD).

Until now, aspirin has been the standard of care for people with CAD and PAD, which affect 16.5 million and 10 million in the US, respectively, but research shows it is “simply not enough to address the underlying risk of blood clots that accompanies these conditions,” Janssen noted.

Xarelto, it says, is now the first and only Factor Xa inhibitor approved for patients living with these conditions.

Approval came on the back of data from the landmark COMPASS trial, which assessed the use of the drug twice daily in combination with aspirin for the long-term prevention of major adverse CV events.

Findings that the drug induced a 23% reduction in deaths in patients with CAD, a 70% reduction in the risk of major amputation, and a 31% cut in the risk of major adverse cardiovascular events (MACE), major adverse limb events (MALE) and major amputation.

On the safety side, the firms also noted that bleeding rates were low, and while major bleeding was increased, there was no significant differences in fatal bleeding, non-fatal intracranial bleeding or bleeding into a critical organ between any of the treatment groups.

“Despite the use of guideline-recommended therapies, patients with chronic CAD and/or PAD remain at risk of having a devastating and irreversible CV event,” said Paul Burton, vice president, medical affairs, Internal Medicine, Janssen Scientific Affairs.

“The new Xarelto vascular 2.5mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD.”