ROCKVILLE, Maryland—FDA has approved a new indication for Pfizer and Eisai's 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. Fragmin is the first low-molecular-weight heparin(Drug information on heparin) approved in the United States for this indication, the companies said in a press release.
The 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 676 patients with cancer, compared with warfarin(Drug information on warfarin), the standard oral anticoagulant. Patients diagnosed with acute DVT, PE, or both were randomized to receive Fragmin for 6 months or Fragmin for 5 to 7 days, followed by warfarin for 6 months.
During the study, 53 of the warfarin patients had at least one episode of DVT or PE vs 27 in the Fragmin arm. Most of the difference occurred during the first month of treatment, and the benefit was maintained over the 6-month study period. Mortality rates were similar between groups at the end of the study.
