Sanofi-Aventis gets EU approval for combo Plavix drug DuoPlavin/DuoCover

French drug major Sanofi-Aventis and marketing partner USA-based Bristol-Myers Squibb received good news this morning with European approval of their dual antiplatelet combination tablet DuoPlavin/DuoCover (clopidogrel 75mg and acetylsalicylic acid 100mg or 75 mg) by the European Commission.

Their already marketed blockbuster blood thin Plavix (clopidogrel) is due to start losing patent protection in 2012, and has recently come under criticism in the USA, where the Food and Drug Administration has called for a boxed warning to be added to the drug, alerting patients and health care professionals that it can be less effective in people who cannot metabolize the compound to convert it to its active form. (The Pharma Letter March 15). Plavix is the second-best selling drug worldwide, with both companies' global revenues reaching $9.5 billion in 2009.

DuoPlavin/DuoCover is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). It is a fixed dose combination for continuation of therapy in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention and for the treatment of ST-segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy.