The Medicines company has announced that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion applicable to all Member States of the EU/European Economic Area that will extend the use of Angiox (bivalirudin) to include patients with heart attacks undergoing primary percutaneous coronary intervention (PCI).
Reportedly, the basis of the approval is HORIZONS-AMI study which was the first drug trial to demonstrate a reduction in deaths from heart attacks in patients undergoing emergency PCI. The trial showed that patients treated with Angiox compared with today’s treatment – heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) – were more likely to survive and had less frequent severe bleeds.
The HORIZONS-AMI trial compared Angiox to heparin plus a GPI in 3,602 patients presenting with the most severe form of heart attack, known as STEMI, undergoing a emergency (primary) PCI.
The company said that results at 30 days showed that Angiox improved overall mortality including a reduction in the incidence of heart-related deaths by 38% (1.8% vs 2.9%, p=0.03), reduced the incidence of major bleeding by 42% (5.1% vs 8.8%, p< 0.0001).
It also reduced the incidence of net adverse clinical events, a composite of major adverse cardiac events or major bleeding, by 26% (9.3% vs 12.7%, p = 0.0015)and demonstrated comparable rates of major adverse cardiac events (5.4% vs 5.5%, p = 0.8901).
Long terms results of the HORIZONS-AMI data confirms the 30-day mortality benefit showing a 38% reduction in cardiac mortality at 30 days, which was maintained at 43% (at one year) and 41% (at two years).
Gilles Montalescot of the Pitie-Salpetriere Hopital, France, said: “The HORIZONS-AMI trial confirms the role of Angiox as an alternative anticoagulant strategy to treat patients with acute myocardial infarction undergoing primary PCI. The safety benefit observed with bivalirudin against unfractionated heparin + GPIIb/IIIa inhibitors is a real contribution to interventional cardiology in the contemporary era of evidence based medicine.”