Canyon PharmaceuticalsTM (www.canyonpharma.com) today announced the availability of Iprivask (desirudin for injection), the first direct thrombin inhibitor (DTI) approved in the United States by the Food and Drug Administration (FDA) for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism in patients undergoing elective hip replacement surgery.
“Significant need exists in the US for alternatives to heparin-based anticoagulants that are more effective and easier to use than currently available DTIs. Desirudin becoming available is a step forward in that direction”
In head-to-head clinical trials, Iprivask was found to be superior to both heparin and low-molecular weight heparin (LMWH) enoxaparin for the prevention of proximal DVT and for major venous thromboembolic events (VTE) after elective hip replacement surgery. VTE, one of the most common complications in surgical patients, is associated with increased hospital costs, length of stay, morbidity, and mortality.
Vic Tapson, MD, Professor of Medicine at Duke University, said: “Desirudin is an important advance and promises to be a valuable alternative to heparin-based DVT prophylaxis agents."
Few alternatives exist to heparin-based anticoagulation for DVT prophylaxis in the hospitalized patient. VTE prophylaxis therapy with heparin-based anticoagulation can be complicated by a variety of untoward events including thrombocytopenia, which has been shown to increase short-term mortality. The development of thrombocytopenia often results in suspension of VTE prophylaxis with heparin leaving patients unprotected for a period of time due to the lack of alternatives.
“Significant need exists in the US for alternatives to heparin-based anticoagulants that are more effective and easier to use than currently available DTIs. Desirudin becoming available is a step forward in that direction,” said Craig Kessler, MD, Georgetown University Professor of Medicine and Pathology and Section Chief of Hematology.
Kessler pointed out that because Iprivask is administered as a fixed subcutaneous dose, “it is easier to use than intravenous DTIs and provides a safer alternative for DVT prophylaxis.”
“Iprivask is a promising advance because it is superior to the current standard of care in preventing proximal DVT and major VTE, with no difference in bleeding,” said Dawn Bell, PharmD, Senior Vice President and General Manager of Canyon Pharmaceuticals. “It does not have a risk for thrombocytopenia or heparin-induced thrombocytopenia, is relatively short-acting, and is easy to monitor."
"We are excited to be launching the first new DVT prophylaxis agent in nearly 10 years,” said Seng Chin Mah, CEO, Canyon Pharmaceuticals. “Iprivask is an important addition to the DVT prophylaxis armamentarium because options for DVT prophylaxis are limited, especially in the peri-operative setting.”
March is DVT Awareness Month
The Coalition to Prevent DVT (www.preventdvt.org) has declared March DVT Awareness Month to raise awareness of this serious medical condition among consumers, healthcare professionals, and government and public health leaders. According to the American Heart Association (www.americanheart.org), up to two million Americans are affected annually by DVT. Of those who develop pulmonary embolism (PE), up to 200,000 will die each year. More Americans die annually from DVT/PE than from breast cancer and AIDS combined (ClotCare).
The Office of the Surgeon General and the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health recently issued a “Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism.” The report acknowledged that substantial gaps exist in our knowledge of how to best provide adequate VTE prophylaxis in certain patient subgroups.