Novo Nordisk receives FDA approval for first-ever room-temperature stable hemophilia treatment

PRINCETON, N.J. Novo Nordisk’s NovoSeven RT, the first room-temperature stable recombinant drug for hemophiliacs with inhibitors, received approval from the Food and Drug Administration Tuesday.

NovoSeven RT is room-temperature stable, meaning that it remains stable at temperatures between 36 and 77 degrees and does not require refrigeration. NovoSeven RT’s also has a higher concentration so that infusions require almost half the amount of the original NovoSeven. It is the first room-temperature stable treatment for hemophiliacs with inhibitors not derived from plasma, thus eliminating the risk of viral transmission.

NovoSeven RT is a new formulation of NovoSeven, Novo Nordisk’s Coagulation Factor VIIa product designed for treatment of bleeding episodes in people with hemophilia A and B with inhibitors to Factor VIII and Factor IX and people with acquired hemophilia, as well as prevention of bleeding during surgery and invasive procedures. They are also used to treat patients with congenital Factor VII deficiency.

NovoSeven RT will become available in August.