Posted by Michael Wonder on 30 Jul 2018
Bayer receives positive CHMP opinion for rivaroxaban for patients with coronary or peripheral artery disease
27July 2018 - Positive CHMP opinion based on data from the largest Phase III rivaroxaban study, COMPASS.
The CHMP of the EMA has adopted a positive opinion for a new indication of Bayer´s oral Factor Xa inhibitor Xarelto (rivaroxaban). The regimen of Xarelto 2.5 mg twice daily plus aspirin 75 – 100 mg once daily will be indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events.
The positive opinion is based on data from the COMPASS study, the largest Phase III study with rivaroxaban (27,395 patients), which showed that the rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily reduced the risk of the composite of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared with aspirin 100 mg once daily alone in patients with CAD or PAD.
