WASHINGTON (Reuters) - Denmark's Novo Nordisk won U.S. approval to sell a new formulation of a genetically engineered protein therapy that helps the blood clot, regulators said on Friday.
The product, NovoSeven RT, can be stored at room temperature for up to two years, the Food and Drug Administration said. An older formulation had to be refrigerated.
NovoSeven RT is a genetically engineered version of Factor VIIa, a protein found in plasma that is essential for the clotting of blood.
Approved uses of NovoSeven RT include treatment of bleeding, and prevention of surgical bleeding, in certain patients with hemophilia.
The most commonly observed reactions with NovoSeven RT include fever, bleeding, injection site reactions, joint discomfort, headaches, and elevations or falls in blood pressure, the FDA said.
Some elderly patients had an increased risk of arterial clots when treated with NovoSeven RT for unapproved uses, the FDA added.
(Reporting by Lisa Richwine; editing by John Wallace)
