Bayer has announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended that rivaroxaban (Xarelto) 2.5mg twice-daily (in combination with standard antiplatelet therapy) be approved for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) with elevated cardiac biomarkers.
According to a company press release, the final decision of the European Commission on the approval is expected in the first half of this year.
Data from the pivotal Phase III ATLAS ACS 2-TIMI 51 study of more than 15,500 patients demonstrated that the addition of rivaroxaban 2.5mg BID to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those who received standard antiplatelet therapy alone.
Rates of TIMI (Thrombolysis In Myocardial Infarction) major bleeding events not associated with coronary artery bypass graft (CABG) surgery were low overall, yet increased with the addition of rivaroxaban. But importantly, there was no increase observed with rivaroxaban in the risk of fatal intracranial haemorrhage (ICH) or fatal bleeding.
“Today’s recommendation by the CHMP is recognition that Xarelto 2.5mg BID plus standard antiplatelet therapy can help save lives by reducing the risk of heart attack, stroke or cardiovascular death for patients with acute coronary syndrome,” said Kemal Malik, a member of the Bayer HealthCare Executive Committee and head of Global Development.