Arixtra receives Approvable Letter

Published: 22-Oct-2001
Regulatory


Sanofi-Synthelabo and Organon have received an Approvable Letter for their new antithrombotic drug Arixtra (fondaparinux sodium) from the FDA for the prevention of venous thrombo-embolic events following orthopedic surgery.

The new drug application for fondaparinux sodium, the active ingredient in Arixtra, was submitted last February, and was granted a six-month priority review; this is granted by the FDA when a drug is expected to offer a significant improvement over products currently marketed for the disease.

The companies expect to establish a strong position in the antiothrombotic field with this new drug. Further clinical investigation is being carried out to extend Arixtra's use for the treatment of venous thrombosis and pulmonary embolism (Phase III) and the treatment of thrombo-embolic disease (Phase IIb). Arixtra, an entirely synthetic compound, is the first in a new class of antithrombotic agents that selectively inhibit Factor Xa.

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