The US Food and Drug Administration (FDA) has approved a new indication for Fragmin (dalteparin sodium injection), for the extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer.
VTE is the formation of a blood clot that can travel from a leg vein to the lung, with potentially fatal results. Fragmin is the first low-molecular-weight heparin (LMWH) approved in the US for the extended treatment of recurrent VTE in patients with cancer.
"Cancer treatments and the disease itself put this patient population at significantly higher risk than non-cancer patients for developing DVT or PE, the two conditions described as VTE," said Frederick Rickles, MD, FACP, clinical professor of medicine at George Washington University Medical Centre.
VTE is a frequent medical complication for patients with cancer. Patients with cancer have an increased risk of VTE compared to those without cancer. Additionally, patients with cancer may be immobilized, which predisposes the patient to this condition.
Today's FDA approval is based on data from the CLOT study, which evaluated the safety and efficacy of Fragmin in reducing the recurrence of DVT/PE in patients with cancer, compared to an oral anticoagulant. Patients diagnosed with acute DVT, PE or both were randomized into two groups of 338 patients each. One group received Fragmin for six months. The other group received Fragmin for five to seven days, followed by warfarin for six months. Warfarin is an oral anticoagulant that has been used for many years as the standard drug in the long-term treatment of VTE.
The CLOT study showed that, during a six-month period, nearly twice as many patients (53) treated with warfarin experienced at least one episode of DVT or PE compared to those treated with a once-daily administration of Fragmin (27). Most of the difference occurred during the first month of treatment. The benefit was maintained over the six-month study period. Mortality rates were similar between the study groups at the end of the study. The safety findings were numerically higher for the Fragmin group versus the warfarin group for major bleeding, thrombocytopenia (drop in platelet count) and liver enzyme elevations. Results from the CLOT study were published in the July 10, 2003 issue of the New England Journal of Medicine.
"The CLOT study provides clinical evidence that Fragmin is more effective than traditional oral anticoagulant therapy in reducing risk of recurrent VTE in patients with cancer" said Dr. Rickles. "Physicians now have an FDA-approved low-molecular-weight heparin specifically for extended treatment to reduce the recurrence of blood clots in patients with cancer."
Eisai licensed exclusive US rights to promote Fragmin from Pfizer Inc in September 2005, and has assumed responsibility for product distribution. This agreement for Fragmin is aimed at strengthening Eisai's position in oncology and critical care in the United States. Eisai and Pfizer currently have three product alliances.
In the United States, Fragmin is also indicated for prevention of DVT, which may lead to PE, in patients undergoing hip replacement surgery, in at-risk patients undergoing abdominal surgery and in at-risk acutely ill patients whose mobility is severely restricted. Fragmin is also approved for prophylaxis of ischemic complications resulting from unstable angina and non-Q-wave myocardial infarction (heart attack), when used with aspirin.
Fragmin is a registered trademark of Pfizer Health AB and is licensed to Eisai Inc.