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L & # 39; Ema Chmp adopted a positive opinion for the extension of the indications of rivaroxaban. The new indication approved as a preliminary point is as follows: rivaroxaban, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral arterial disease . high risk of ischemic events
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a favorable opinion on the extension of the indications of rivaroxaban. The new indication approved as a preliminary point is as follows: rivaroxaban, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral arterial disease . The European positive opinion is based on the results of the Phase III study of the COMPASS program presented last year at the Congress of the European Society of Cardiology and whose data has was simultaneously published in the New England Journal of Medicine, the study showed that the use of rivaroxaban plus aspirin reduces the risk of cardiovascular events (CV) by 24% in patients with stable coronary heart disease. or a MAP compared to aspirin alone
. ] In addition, the results of the study showed that the combination of rivaroxaban and aspirin reduced the risk of stroke by 42 percent and CV deaths by 22 percent or, compared with aspirin alone. In addition, rivaroxaban plus aspirin is badociated with a 20% improvement in net clinical benefit, defined as the reduction of strokes, cardiovascular deaths and heart attacks against the most serious bleeds.
Hemorrhagic events were mild and, especially, despite an increase in major bleeding, there was no significant increase in fatal bleeding or intracranial bleeding. The relevant point to note is that in populations of patients with peripheral arterial diseases (PAD), there has been a significant reduction in major adverse events that affected the limbs, and all major amputations of the vascular cause.
It is estimated that each year, mortality from cardiovascular diseases, including coronary artery disease and peripheral arterial disease, reaches approximately 17.7 million people, or 31% of global mortality. In addition, those who suffer from cardiovascular diseases have a reduced life expectancy of more than 7 years. Coronary artery disease (CAD) and peripheral arterial disease (PAD) are caused by atherosclerosis, a chronic progressive disease characterized by an accumulation of fat and scar tissue in the arteries. Those who suffer from these conditions are at risk of developing thrombotic events that can result in disability, limb loss and death.
The company said that if this indication is approved, about 30 million more patients could potentially benefit from the oral factor Xa inhibitor. Bayer generated 3.3 billion euros of revenue in Xarelto last year and expects to achieve an annual business turnover of more than 5 billion euros. ; euro.
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