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news.The FDA has approved a new indication for blood clot drug Fragmin to treat symptomatic venous thromboembolism in patients with cancer, according to the drug's developers Pfizer and Eisai.
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Symptomatic venous thromboembolism (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 approved in the US for the extended treatment of recurrent VTE in patients with cancer.
The approval is based on data from a study which showed that, during a six-month period, nearly twice as many patients treated with standard anti-coagulant treatment warfarin experienced at least one episode of DVT or PE, the two conditions described as VTE, compared to those treated with a once-daily administration of Fragmin. Mortality rates were similar between the study groups at the end of the study, while safety rates were higher for the Fragmin group.
Eisai licensed exclusive US rights to promote Fragmin from Pfizer in 2005, and has assumed responsibility for product distribution.