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| |  FDA Approves Once-Daily Innohep (Tinzaparin) For Deep Vein Thrombosis WILMINGTON, DE -- July 18, 2000 -- DuPont Pharmaceuticals Company announced that its once-daily low molecular weight heparin medication Innohep® (tinzaparin sodium injection) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute symptomatic deep vein thrombosis (DVT) with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of Innohep were established in hospitalized patients. DuPont Pharmaceuticals, a wholly owned independent subsidiary of DuPont, obtained the U.S. marketing rights for Innohep from Leo Pharmaceutical Products, a Danish firm that markets the product in more than 20 countries outside the United States. "We are very pleased with FDA's rapid 10-month initial review to approve Innohep," said Nicholas L. Teti, president and chief executive officer of DuPont Pharmaceuticals. "Obtaining the approval of this important new low molecular weight heparin product demonstrates our commitment to anticoagulation patients and to on-going thrombosis research as part of our overall business strategy." Venous thromboembolic disease, including DVT, is a common yet serious disorder that affects approximately five million Americans annually. It can lead to pulmonary embolism (PE), which develops in about 500,000 people each year and is fatal in almost 50,000 individuals annually. Acute DVT alone accounts for almost 800,000 hospitalizations each year. The treatment of DVT -- with or without PE -- has, in recent years, been transformed by the use of low molecular weight heparins. Innohep offers the advantage of being the only once-a-day low molecular weight heparin product for all patients with DVT. In a double-blind clinical trial published in the New England Journal of Medicine that enrolled 435 patients with symptomatic proximal DVT (six percent had coexistent symptomatic PE), Innohep was shown to be equivalent to standard heparin therapy in the prevention of recurrent venous thromboembolism (DVT and/or PE). Total thromboembolic events (DVTs and PEs) were six of 216 patients (2.8 percent) in the Innohep treatment arm and 15 of 219 patients (6.8 percent) in the intravenous (I.V.) heparin treatment arm. The 95 percent confidence interval for the total thromboembolic event rate difference (4.0 percent) was 0.07 percent, 8.07 percent. Mortality with Innohep was 4.6 percent (10 patients) and with heparin 9.6 percent (21 patients). The 95 percent confidence interval for the mortality difference was 0.16 percent, 9.76 percent. The most common adverse event in controlled clinical trials evaluating Innohep for DVT treatment was bleeding; however, the incidence of major bleeding was low (0.8 percent of 519 patients treated with subcutaneous Innohep as compared to 2.7 percent of 524 patients treated with I.V. heparin). Other bleeding events (occurring at a frequency of greater than or equal to 1 percent) associated with Innohep treatment were epistaxis (1.9 percent), hemorrhage (1.5 percent) and hematuria (1.0 percent). Like other anticoagulants, Innohep should be used with caution in conditions with increased risk of hemorrhage. Related links: Innohep, DuPont Pharmaceuticals.
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