Sanofi's heart disease therapy DuoPlavin gets EU drug regulator's nod for expanded approval

RomanBabakin

• A committee of the European Medicines Agency (EMA) recommended the expanded approval of Sanofi's (NASDAQ:SNY) heart disease drug DuoPlavin.
• The active substance in DuoPlavin is clopidogrel and acetylsalicylic acid.
• The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a change to the existing indication to include the secondary prevention of atherothrombotic events in patients with ST segment elevation acute myocardial infarction (heart attack) undergoing percutaneous coronary intervention (PCI).
• PCI is a procedure used to open blocked coronary (heart) arteries.
• The European Commission, which generally follows the opinion of the CHMP, will now decide on the change to the terms of the marketing authorization of DuoPlavin.