The active ingredient in NovoEight is turoctocog alfa, a B-domain truncated recombinant antihemophilic factor which is produced by third generation recombinant DNA technology
Novo Nordisk has launched Novoeight, (antihaemophilic factor [recombinant]) in India for use in the treatment and prevention of bleeding in people with haemophilia A (congenital factor VIII deficiency) across all age groups. It can also be used to prevent excessive bleeding in people with haemophilia A undergoing surgery.
Congratulating Novo Nordisk India, Mads Bo Larsen, Corporate Vice President Business Area Gulf, India and Egypt said, “The approval of Novoeight marks an important step in offering a new alternative for people with haemophilia A, and demonstrates our commitment to haemophilia.”
Haemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with haemophilia A are either missing or have a malfunctioning factor VIII protein, which is essential for proper blood clotting. People with haemophilia A have a tendency to bleed longer than most or to bleed internally into joints, muscles or organs because they are missing this clotting factor. To manage the disease and stop bleeding, people with haemophilia A must replace the missing factor VIII protein, which is accomplished by intravenous injection of the clotting factor.
The active ingredient in NovoEight is turoctocog alfa, a B-domain truncated recombinant Antihemophilic Factor which is produced by third generation recombinant DNA technology. This means that it is prepared without the addition of any human or animal derived protein in the entire manufacturing process. Reportedly, in addition it undergoes a five-step purification process which includes two dedicated viral clearance steps – a detergent treatment step for inactivation of enveloped viruses and nanofiltration with 20 nm pore size membranes that reduces infectivity due to prions and small non-enveloped viruses. This results in significant reduction in the risk of allergy or infections, otherwise present in currently marketed recombinant or plasma derived FVIII products in India, claims a company release.
Speaking at the launch, Melvin D’souza, Vice President and General Manager, Novo Nordisk India said, “With the launch of Novoeight that is manufactured by third generation recombinant DNA technology, this becomes first such therapy that will be made available for benefit of people with haemophilia A in India.”
The release also states that Novoeight offers enhanced portability and convenience as it comes with an intuitive device for reconstitution and advantage of highest storage temperature for the longest period of time (up to 300C for nine months) compared with the marketed recombinant Factor VIII product in India. It can be kept at that temperature for up to four hours after reconstitution, and for up to 24 hours in the refrigerator (20C – 80C).