Akzo Nobel launches Arixtra® in the United States
Arnhem/Oss, the Netherlands, – Akzo Nobel’s business unit Organon and Sanofi-Synthélabo today announced the launch of their antithrombotic drug Arixtra® in the United States. Arixtra, an innovative, synthetically-produced drug, is indicated for the prevention of deep vein thrombosis in patients undergoing surgery of the lower limbs, such as for hip fracture and major knee or hip replacement surgery.
Results of an international Phase III program, which included more than 7,000 patients, have shown that Arixtra provides a superior benefit compared with the reference treatment for major orthopedic surgery patients. Arixtra is the only antithrombotic agent indicated in the United States for hip fracture surgery.
Prevention of deep venous thrombosis in orthopedic surgery patients is the first of a range of indications that are in late-stage clinical development. The total worldwide sales potential for these combined clinical applications is estimated to be in excess of EUR 1 billion after 2006. This sales level is expected to be achieved gradually, as the new indications are approved.
Arixtra was approved in the United States by the Food and Drug Administration (FDA) on December 7, 2001 and was recently made available to wholesalers in preparation for launch. It will be presented at the Annual Meeting 2002 of the American Academy of Orthopedic Surgeons (AAOS) in Dallas, Texas, starting on February 13, 2002.
In the European Union, the Committee for Proprietary Medicinal Products (CPMP) gave a positive opinion for Arixtra in December 2001, recommending that marketing authorizations should be granted for the drug.
Arixtra is a synthetic compound and the first in a new class of antithrombotic agents that selectively inhibits Factor Xa, a naturally occurring blood clotting factor. Arixtra was discovered and is being co-developed by Sanofi-Synthélabo and Organon, who will market the drug in the United States as partners in a joint venture.
The launch of Arixtra first in the United States will reinforce Organon’s position there and underlines Akzo Nobel’s, and in particular Organon’s, strong focus on the U.S. market. Organon is also moving its international headquarters to Roseland, New Jersey, in the U.S.
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