Novo Nordisk, a leading player in haemophilia care, has launched Novoeight,(Antihemophilic 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: “We are very excited about having reached this goal. Turoctocog alfa represents a new treatment alternative for people with haemophilia A and is one of the first important outcomes of the haemophilia research strategy we embarked upon about a decade ago. 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. In addition it undergoes a 5-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.
Speaking at the launch, Melvin D’souza, vice president and general manager, Novo Nordisk India Pvt Ltd said: “For the last decade, Novo Nordisk is working towards improving lives of people with haemophilia through support to improved diagnosis, treatment and care. We offer a broad and innovative range of products to ensure that we are in the forefront of finding the next generation of medicines. 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.”
Also present at the launch was Dr Cecil Ross, vice president, Haemophilia Federation India. He said he was happy that Turoctocog alfa is another treatment option introduced by Novo Nordisk. “There must be more players in the market to benefit the wider haemophilia community. This is a new alternative in factor VIII treatment. It is based on the most advanced protein and purification technology and has been designed to expand reliability, safety and portability for people with haemophilia A.”
Dr Naresh, chief of Haemophilia Day care centre, Maulana Azad Medical College New Delhi who was present at the launch said: “Turoctocog alfa bespeaks of Novo Nordisk's commitment to wider haemophilia community with the pioneering launch of this third generation recombinant clotting Factor VIII, a first in India.”
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 9 months) compared with the marketed recombinant Factor VIII product in India. It can be kept at that temperature for up to 4 hours after reconstitution, and for up to 24 hours in the refrigerator (20C – 80C) giving it the longest post reconstitution storage time.
Novoeight contains human coagulation factor VIII (rDNA), turoctocog alfa, a glycoprotein that has the same structure as human factor VIII when activated. When infused into a haemophilia patient, Novoeight binds to endogenous von Willebrand factor in the patient’s circulation. This is essential for factor VIII to bring its desired action without premature degradation. Upon activation, Novoeight acts as a co-factor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed.