By Fineline Cube The Center for Drug Evaluation (CDE) in China has indicated on its website that the market filing for turoctocog alfa pegol, developed by Denmark-based Novo Nordisk (NYSE: NVO), has been accepted for review. The drug is intended for the treatment of hemophilia A, a genetic bleeding disorder.
Turoctocog Alfa Pegol: A Long-Acting Recombinant Coagulation Factor VIII
Turoctocog alfa pegol, a long-acting recombinant coagulation factor VIII (FⅧ), was first approved for use in the US in February 2019 for preventive and acute treatment of adults and children with hemophilia A. The drug was subsequently approved in the European Union in June 2019 and in Japan three months later, marking its global expansion in addressing the needs of hemophilia A patients.
Market Presence and Benefits in China
In China, seven recombinant coagulation factor VIII products are commercially available, including products from major pharmaceutical companies such as Bayer, Baxter, and Pfizer. Among these, Novo Nordisk’s NovoEight is a notable product. Turoctocog alfa pegol, modified based on NovoEight, improves the half-life by twofold. Administered once every four days, the drug can significantly reduce the annual bleeding rate of patients by 96%, offering a more convenient and effective treatment option for those with hemophilia A.-Fineline Info & Tech