The anti-thrombotic drug Arixtra is now indicated for use in patients undergoing abdominal surgery, GlaxoSmithKline announced here.
The US FDA approved the supplemental New Drug Application (sNDA) for Arixtra in the prevention of venous thromboembolism (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.
"Since many patients undergoing abdominal surgery are at high risk of developing VTE, the FDA's approval of Arixtra for this new indication represents an important and exciting medical development," Kevin Lokay, vice president of GlaxoSmithKline Oncology and Acute Care said adding, "This approval provides these high risk patients, particularly cancer surgery patients, the benefit of VTE protection in a once-a-day anticoagulant."
Arixtra is the first selective inhibitor of Factor Xa, a protein central to the coagulation process. Arixtra is already approved for the prevention of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing surgery for hip fracture (including extended prophylaxis), knee replacement and hip replacement. Additionally, Arixtra is indicated for the treatment of acute DVT when administered in conjunction with warfarin sodium and for the treatment of acute PE when administered in conjunction with warfarin sodium, when initial therapy is administered in the hospital.
VTE is a term that refers to either one or both of two medical conditions: deep vein thrombosis (DVT, which includes blood clots in the pelvic or leg veins), and pulmonary embolism (PE, which is when a clot breaks off and lodges in the lung arteries).
The recent approval of Arixtra for patients undergoing abdominal surgery is based on the results of the PEntasaccharide GenerAl SUrgery Study (PEGASUS). This non-inferiority study demonstrated that Arixtra is at least as effective as dalteparin in reducing the risk of VTE. In the study, 4.6 per cent of patients receiving Arixtra experienced a VTE incident versus 6.1 per cent of patients on dalteparin. Sixty-nine per cent of the patients in the study underwent cancer-related abdominal surgery with 4.7 per cent of patients in the Arixtra group experiencing VTE versus 7.7 per cent of patients in the dalteparin group. In non-cancer abdominal surgery patients studied, 4.2 per cent of patients receiving Arixta experienced VTE versus 2.3 per cent of patients receiving dalteparin.