Akzo Nobel’s pentasaccharide drug granted "fast-track" review by FDA
Akzo Nobel’s business unit Organon and Sanofi-Synthélabo have just received notification from the United States food and Drug Administration (FDA) that they will follow a “fast-track” approval procedure for the new antithrombotic pentasaccharide drug that was filed for registration with the FDA on February 15, 2001.
Fast-track approval is usually granted to new drugs that show clear potential for the treatment of a serious or life-threatening condition that cannot be provided by existing therapies. The application to the FDA is for use of pentasaccharide (fondaparinux sodium) in the prevention of thrombosis following major orthopedic surgery.
Organon intends to establish a strong position in the antithrombotic field with this new totally synthetic drug. To broaden the potential use of pentasaccharide, advanced clinical trials are being carried out to extend its use to the treatment of thrombosis and pulmonary emboli (phase III) and to the treatment of arterial thrombosis (phase 2B).
The pentasaccharide compound was discovered and is being co-developed in a collaboration between Organon and Sanofi Synthélabo (France).
Pentasaccharide was also filed for registration in Europe on February 15, 2001.
Organon is a renowned global pharmaceutical company with a strong commitment to health care. The company develops and produces innovative prescription medicines for gynecology, psychiatry, cardiovascular disease and immunology. Organon products are sold in over 100 countries, more than half of which have an Organon subsidiary. The company currently employs around 12,000 people. N.V. Organon is the ethical pharmaceutical Business Unit of Akzo Nobel.
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