Xarelto gets ACS indication
pharmafile | May 29, 2013 | News story | Sales and Marketing | ACS, Bayer, Xarelto
Bayer HealthCare’s bloodthinner Xarelto has expanded its reach in Europe with approval for secondary prevention after an acute coronary syndrome (ACS).
This indication for Xarelto (rivaroxaban) – its seventh – is designed to help the one in ten patients who experience cardiovascular death, myocardial infarction or stroke within a year of an ACS event.
The Phase III ATLAS ACS 2-TIMI 51 study showed that adding Xarelto 2.5 mg BID twice-daily to standard antiplatelet therapy – low-dose aspirin with or without a thienopyridine (clopidogrel or ticlopidine) – offered significant protection to this patient group compared to standard therapy alone.
Arterial blood clots, which can lead to a recurrence after an ACS event, form via both platelet activation and thrombin generation, and Xarelto targets Factor Xa, a key trigger of the latter.
“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk,” said C. Michael Gibson, ATLAS’s principal investigator.
“We’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk,” he added.
This marks, Gibson concluded, ‘an important shift’ in the way patients who are at risk of a secondary atherothrombotic event are looked after.
This expanded indication makes the drug the only novel oral anticoagulant approved to protect patients with elevated cardiac biomarkers following an ACS.
Xarelto has already got the green light to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism – and to prevent their recurrence – as well as to prevent venous thromboembolism in adults having a hip or knee replaced.
“Xarelto is already finding extensive use by cardiologists for stroke prevention in patients with atrial fibrillation,” said Kemal Malik, Bayer’s head of global development. “This approval re-enforces the compelling profile of the product, further extending its clinical value in preventing arterial blood clots.”
Rates of major bleeding events not associated with coronary artery bypass graft surgery and of intracranial haemorrhage (ICH) increased with the addition of Xarelto, but Bayer says there was no increase observed in the risk of fatal ICH or fatal bleeding.
The 2012 European Society of Cardiology guidelines recommend that Xarelto should be considered for patients with ST-Segment Elevation Myocardial Infarction (STEMI) who are at low bleeding risk, and are on antiplatelet therapy with aspirin and clopidogrel.
Adam Hill
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