Source: Lancet  |  Posted 10 years ago

PARIS, FRANCE -- February 8, 2002 -- Sanofi-Synth?labo and Organon announced today that Arixtra? (fondaparinux sodium) has been launched in the United States by the Organon Sanofi-Synth?labo L.L.C. joint venture.
Arixtra is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing hip fracture surgery, hip replacement surgery or knee replacement surgery.
The results of the international Phase III program, which included more than 7,000 patients, have shown that Arixtra provides a superior benefit versus the reference treatment in major orthopedic surgery patients. It is the only anti-thrombotic agent indicated in hip fracture surgery in the United States.
Arixtra was approved in the United States by the Food and Drug Administration (FDA) on December 7, 2001 and was made available to wholesalers on January 28, 2002. It will be presented at the Annual Meeting 2002 of the American Academy of Orthopaedic Surgeons (AAOS) in Dallas, Texas, starting on February 13, 2002.
In the European Union, the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion recommending to grant a marketing authorisation for Arixtra in December 2001.
Arixtra is a synthetic compound and the first in a new class of antithrombotic agents that selectively inhibit factor Xa. It was discovered and is being co-developed by Sanofi-Synth?labo and Organon.
SOURCE: Sanofi-Synthelabo