BETHESDA, MD 17 Oct 2013—FDA on October 15 approved Novo Nordisk's recombinant antihemophilic factor for use in the treatment, management, and routine prophylaxis of bleeding in children and adults with hemophilia A.
Known as Novoeight, the product will become available soon after April 2015, once certain patents have expired, the company said.
Tables in the product's labeling (PDF) state the dosages for controlling and preventing bleeding episodes, managing the disease when a patient undergoes surgery, and using the biological agent three times weekly or every other day to prevent or reduce the frequency of bleeding episodes.
During the clinical studies of the recombinant antihemophilic factor, the most frequently reported adverse reactions were injection-site reactions, increases in the levels of hepatic enzymes, and fever. The studies, the labeling states, involved only male patients.
Patients who have had life-threatening hypersensitivity reactions to Novoeight or hamster proteins must not receive the product. The recombinant protein in the product is synthesized in Chinese hamster ovary cells.
Novoeight will be available in single-use vials containing 250, 500, 1000, 1500, 2000, or 3000 international units of antihemophilic activity.
Each package will contain one vial of the biological agent, one syringe prefilled with 0.9% sodium chloride injection and accompanied by a plunger rod, and a vial adapter with 25-µm filter. The labeling has step-by-step instructions, with pictures, for preparing a dose.
After reconstitution of the biological agent, it may be stored for as long as four hours at room temperature.
The FDA-approved labeling describes the active ingredient in Novoeight as a recombinant analogue of human coagulation factor VIII but does not provide a name for that analogue. FDA's European counterpart refers to the active ingredient as turoctocog alfa.