Bayer Korea said it has obtained approval for an expanded indication for Xarelto (ingredient: rivaroxaban) to reduce cardiovascular risks in patients with a coronary artery disease or symptomatic peripheral artery disease. Xarelto is a non-vitamin K antagonist oral anticoagulant (NOAC).
The company said Xarelto became the first NOAC to show efficacy in reducing the risk of atherosclerotic events such as stroke, myocardial infarction, and cardiovascular malfunction-induced death. This proves that the blood thinner is an innovative medicine, it added.
The Ministry of Food and Drug Safety granted the nod for Xarelto’s indication to reduce the risk of atherosclerotic events, in combination with aspirin, in adult patients with coronary artery disease or symptomatic peripheral arterial disease with a high risk of ischemic events.
“Although there has been a medical advancement to prevent cardiovascular diseases, there was still an unmet demand to prevent cardiovascular events in patients with coronary artery disease or peripheral vascular disease,” said Han Kyoo-rok, chairman of the Korean Society of Interventional Cardiology.
“The combination of anticoagulant Xarelto and antiplatelet agent aspirin showed that it was possible to prevent ischemic events more effectively,” he went on to say.
Han predicted that Xarelto would become a new treatment option for patients with high-risk coronary artery disease such as multivessel disease and myocardial infarction, and patients with the symptomatic peripheral arterial disease.
The ministry’s approval was based on COMPASS clinical trials in 27,395 patients in 30 countries who had either coronary artery disease or peripheral arterial disease, or both.
In the study, the combo of Xarelto 2.5mg (twice a day) and aspirin 100mg (once a day) lowered the relative risk of stroke, cardiovascular-related death, and myocardial infarction, by 24 percent, compared to aspirin alone.
“The expansion of the indication is significant in that it increased the possibility of preventing cardiovascular events such as stroke, myocardial infarction and cardiovascular death in patients with high risk of ischemic events. At the same time, it confirmed the new potential of Xarelto,” Bayer Korea CEO Ingrid Drechsel said
The company said it has won approval for Xarelto in about 130 countries and has six indications, the most among NOACs.