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M2 PHARMA-July 8, 2014-The Medicines Company renews marketing approval for Angiox in Europe for treating adult patients undergoing percutaneous coronary intervention (PCI)
Healthcare company The Medicines Company (NasdaqGS:MDCO) reported on Monday the receipt of renewal of marketing approval for Angiox (bivalirudin) in Europe, reconfirming its favorable risk-benefit profile, for treating adult patients undergoing percutaneous coronary intervention (PCI).
The marketing approval was renewed by the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) and the European Commission following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan.
This renewal is applicable to Angiox in all Member States of the European Union/European Economic Area.
M2 EQUITYBITES-July 8, 2014-The Medicines Company renews marketing approval for Angiox in Europe for treating adult patients undergoing percutaneous coronary intervention (PCI)
1 December 2009 - US-based pharmaceutical company The Medicines Company (NASDAQ: MDCO) announced today that it has received European approval for the use of Angiox (bivalirudin) as an anticoagulant in patients with heart attacks (so-called ST-segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI).
The Commission Decision extends the current EU licence for Angiox and is applicable to all Member States of the European Union/European Economic Area.
The trial showed that patients treated with Angiox compared with today's leading treatment - heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) - were more likely to survive and had less frequent severe bleeds.
Clive Meanwell, chief executive officer of The Medicines Company, said that the company is grateful to the European Commission and the EMEA for this expeditious approval for Angiox in primary PCI for STEMI.