BiotechTracker - Study Supports Arixtra Label Expansion
June 10, 2003,The PENTasaccharide in HIp-FRActure Surgery Plus (PENTHIFRA Plus) Investigators, led by Eriksson and Lassen, published results of a randomized, double-blind, placebo-controlled trial demonstrating the utility of Sanofi-Synthelabo (NYSE: SNY) and Organon’s (a division of Akzo Nobel, NASDAQ: AKZOY) Arixtra (fondaparinux) as extended use prophylaxis after hip fracture surgery. The manuscript, which supports a supplemental NDA submitted to the FDA on December 17, 2002, was published in the June 9, 2003 issue of Archives of Internal Medicine. Post-operative Arixtra use for 3 extra weeks in this setting is associated with a 95.9% relative risk reduction, versus placebo, of venous thromboembolism (VTE). The data support U.S. label expansion to include the extended dosing protocol. Arixtra is under 6-month, FDA priority review for the protocol assessed in this investigation.  656 patients undergoing hip fracture surgery were randomized to receive once-daily prophylaxis with either subcutaneous Arixtra 2.5 mg or subcutaneous placebo for 19 to 23 days. All of the study subjects had received the usual course of 6 to 8 days of post-operative Arixtra prophylaxis.  428 evaluable patients generated data. Statistically and clinically significant Arixtra advantages included:  VTE relative risk reduction of 95.9% – 35.0% (77/220) versus 1.4% (3/208)  symptomatic VTE relative risk reduction of 88.8% – 2.7% (9/330) versus 0.3% (1/326).  Arixtra’s clinically relevant adverse bleeding event profile was reassuring.  Arixtra is the first direct thrombin inhibitor indicated for use in the management of VTE, including deep vein thrombosis and pulmonary embolism. It is being studied for expanded use in more high-risk VTE prevention scenarios, VTE treatment, and acute coronary syndrome treatment.
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