FDA Approves Lovenox for Prevention of Blood Clots In Medical Patients with Acute Illness

22-Nov-2000

For the first time, the U.S. food and Drug Administration (FDA) has approved a blood-thinning agent for the prevention of life-threatening blood clots, also known as deep-vein thrombosis (DVT), in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illnesses. Aventis Pharmaceuticals, the U.S. business of Aventis Pharma AG, announced today that the FDA has approved the low-molecular-weight heparin, Clexane/Lovenox (enoxaparin sodium) for the prevention of deep-vein thrombosis, a condition that may lead to pulmonary embolism, in patients with illnesses such as moderate or severe heart failure, respiratory failure, severe infection, back pain, vertebral compression or arthritic episodes. "This important addition to the approved uses of Clexane/Lovenox will ensure the product's future growth by making it available to benefit a significantly larger patient population," said Richard Markham, Chief Executive Officer of Aventis Pharma. "We are confident that Clexane/Lovenox will continue to be the foundation therapy in the prevention and treatment of venous and arterial thrombosis, and maintain its global leadership of the low-molecular-weight heparin market." LANDMARK TRIAL ESTABLISHES NEED FOR BLOOD CLOT PREVENTION According to the MEDENOX (MEDical patients with ENOXaparin) study published in The New England Journal of medicine (Samama, 1999), hospitalized acutely ILL medical (non-surgical) patients are at significant risk for venous thromboembolic events (deep-vein thrombosis or pulmonary embolism), and prophylaxis with Lovenox significantly reduces the risk across a range of patient categories.1 The MEDENOX study is a phase III multicenter, three-parallel-group (enoxaparin 20 mg and 40 mg once daily and placebo), randomized, double-blind, placebo-controlled study involving 1,102 patients from 60 centers in nine countries. It is the first study of more than 1,000 patients using venography to demonstrate that acutely ill medical patients are at significant risk for venous thromboembolism (VTE). The study included patients that were initially bedridden and suffering from heart failure, acute respiratory failure, acute infectious disease, acute rheumatic disorder, or active episodes of irritable-bowel disease, combined with pre-defined VTE risk factors such as obesity and varicose veins. The study demonstrated that enoxaparin sodium 40 mg once daily is effective in reducing the risk of VTE. Assessment of efficacy results established that, at day 14, the incidence of VTE was significantly lower in the enoxaparin 40 mg treated group when compared with placebo (4.4% vs

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