FDA clears Novo Nordisk new coagulation therapy

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The FDA has approved a new formulation of the genetically engineered version of Novo Nordisk’s Factor VIIa, which allows the plasma protein for the clotting of blood to be stored at room temperature (up to 77 F) for up to two years.

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

NovoSeven RT, the genetically engineered version of the NovoSeven Coagulation Factor VIIa, contains sucrose and L-Methionine, which allow for storage at room temperature, helpful for healthcare facilities with limited refrigerated space, the FDA said. The original formula could be stored for three years at temperatures between 36 F and 46 F.

The agency said the most commonly observed adverse reactions with NovoSeven RT are fever, bleeding, injection site reaction, joint discomfort, headache, elevations or falls in blood pressure, nausea, vomiting, pain, swelling and rash. Some elderly patients experienced an increased risk of arterial clotting when they were treated with NovoSeven RT outside of its approved indications, according to the FDA.

Novo Nordisk of Bagsværd, Denmark, manufactures NovoSeven RT and NovoSeven Coagulation Factor VIIa (Recombinant).