Sanofi-Aventis and partner Bristol-Myers Squibb say that regulators in Europe have given the thumbs-up antiplatelet combination DuoPlavin.
The drug, also known as DuoCover,is a combination of the blockbuster Plavix (clopidogrel) and acetylsalicylic acid, the active ingredient in aspirin. The European Commission has approved the drug for the prevention of atherothrombotic events in adults already taking both clopidogrel and ASA.
Specifically DuoPlavin can be used 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. It is also approved for the treatment of ST-segment elevation acute myocardial infarction in medically-treated patients eligible for thrombolytic therapy.
Sanofi said that “robust evidence from large clinical studies has led to the approval” and the new formulation carrying both these antiplatelets in a single tablet will “contribute to reducing daily pill burden for patients”.
Sanofi sues Dr Reddy’s
Meantime, Sanofi’s US unit and Albany Molecular Research are seeking a preliminary injunction against Dr Reddy’s Laboratories in a bid to stop the Indian firm from distributing a generic version of the antihistamine Allegra-D (fexofenadine/pseudoephedrine) across the Atlantic
The motion, filed in a New Jersey court, comes after the US Food and Drug Administration approved Dr Reddy’s copycat version. In September last year, Albany Molecular sued, alleging infringement of patents related to the manufacturing process of the drug, which Sanofi holds the patents on. Israel’s Teva has already launched its version of Allegra-D.
