Novo Nordisk gets approval for 8-mg vial of NovoSeven RT

FDA has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8-mg vial size, making the hemophilia A or B with inhibitors treatment available in 1-, 2-, 5-, and 8-mg vials, Novo Nordisk announced on Aug. 10. The 8-mg vial allows a rapid initiation and administration of the medication for those patients who need a larger dose.

In addition, FDA approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (≤77 °F).

NovoSeven RT is specially formulated to treat patients with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30% of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.

For many patients living with hemophilia with inhibitors, the 8-mg vial will allow for faster reconstitution than their current NovoSeven RT regimen. Those who previously had to use 3 vials to deliver an 8-mg dose will now have to reconstitute only 1 vial. Though the amount of powder in the 8-mg vial is larger than the 5-mg vial, the vial will be the same size, and it will have a yellow cap to distinguish it from the smaller dose.

“When I get a bleed, I want to infuse my treatment right away,” said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition, who has been living with hemophilia with inhibitors most of his life. “The faster I treat a bleed, the sooner I can continue with my daily routine. Using fewer vials will be a positive change for patients.”

The new vial size is expected to be available by November, according to the company.