The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO) Esperoct (turoctocog alfa pegol) is on track for priority review for the treatment of hemophilia A in adults and children. The drug is indicated for on-demand treatment and control of bleeding events, perioperative management, and routine preventive treatment to prevent or reduce the occurrence of bleeding events in patients with congenital coagulation factor VIII deficiency.
Turoctocog Alfa Pegol: A Long-Acting Recombinant Coagulation Factor VIII
Turoctocog alfa pegol, a long-acting recombinant coagulation factor VIII (F VIII), was first approved in the US in February 2019 for preventive and acute treatment of adult and child hemophilia A patients. The drug was subsequently approved in Europe and Japan in June and September 2019, respectively.
Market Presence and Efficacy of Turoctocog Alfa Pegol
Bayer’s recombinant coagulation factor VIII, Kogenate, was the first of its kind to enter the Chinese market, followed by Baxter’s Advate, Pfizer’s Xyntha, Bayer’s Kogenate FS, Novo Nordisk’s NovoEight, Sinocelltech’s AnJiaYin, and GC Pharma’s Greengene. Esperoct, modified based on NovoEight, improves the half-life by twofold. Administered once every four days, the drug has the potential to reduce the annual bleeding rate of patients by 96%, making it a significant advancement in the management of hemophilia A.-Fineline Info & Tech
