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FDA clears new coagulation formulation therapy

The FDA has approved a new formulation of a coagulation agent.

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NovoSeven RT is a genetically engineered version of factor VIIa. According to a press release, the new formulation contains sucrose and L-methionine, which allows the product to be stored at room temperature for up to two years and for even longer at lower temperatures.

The NovoSeven RT formulation is indicated for use in the treatment and prevention of surgical bleeding in patients with either hemophilia A or B or acquired hemophilia. It is also used to treat bleeding in patients whose antibodies neutralize clotting factors VIII or IX as well as in patients with factor VII deficiency.

“Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians,” Jesse L. Goodman, MD, director of the FDA’s Center for Biologics Evolution Research, said in a press release. “As with all FDA–approved products, the agency will monitor NovoSeven RT throughout its life cycle.” – by Eric Raible