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Enoxaparin sodium (enoxaparin) is the world reference Low Molecular Weight Heparin. Enoxaparin consists of a highly complex set of heterogeneous sugars (polysaccharides) derived from biological material1 and resulting from a strictly controlled manufacturing process. Enoxaparin’s exclusive structure, pharmacological and clinical properties are highly dependent on sanofi-aventis proprietary manufacturing process. As of today, the active ingredients of enoxaparin, or any other approved [LMW] Heparins, can not be fully characterized by any scientifically validated technology. In fact, the precise mechanisms by which it derives its safety and efficacy properties have yet to be elucidated.
Enoxaparin’s positive benefit-risk ratio has been established step-by-step even in some of the most critical conditions2. This robust medical-based evidence from more than 200 million real life prescriptions has determined the product’s specific risk to benefit balance which can only be reproduced by using the same consistent proprietary manufacturing process or through head-to-head clinical comparison as recently recommended by the EMEA guidelines3.
Today enoxaparin is prescribed in a wide range of potentially life-threatening conditions such as prophylaxis or treatment of venous thromboembolic events4. Unlike other [LMW] Heparins, enoxaparin has also been approved in some particularly serious settings in acute coronary syndromes4.
1. Jack Hirsh, CM, MD, FCCP; and Robert Raschke, MD, MS Heparin and Low-Molecular Weight Heparin. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. CHEST. 2004;126:188S–203S.
2. Fareed J et al. Pharmacodynamic and Pharmacokinetic Properties of Enoxaparin Implications for Clinical Practice. Clin Pharmacokinetic. 2003;42(12):1043-1057.
3. EMEA. Guideline on non-clinical and clinical development of similar biological medicinal products containing Low-Molecular-Weight-Heparin. EMEA/CHMP/BMWP/118264/2007.
4. Lovenox® (enoxaparin sodium injection) Prescribing information. Sanofi-aventis Pharmaceuticals Inc, NJ 2009.
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