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Novo Nordisk submitted to the EMA long-acting clotting factor


Danish pharmaceutical giant Novo Nordisk today announced that the European Medicines Agency has (EMA) submitted a long-acting factor IX product nonacog beta pegol (promise that lectin β pegol) of the marketing authorization application (MAA). The drug is a pegylated glycosylated recombinant coagulation factor IX, has significantly improved pharmacokinetic drug (PK) properties, developed for the treatment of hemophilia B.


Regulation in the United States, Novo Nordisk plans to submit promise that lectin β pegol biologics license application (BLA) in the first half of 2016 to the FDA.


Submit promise that thromboxane β pegol regulatory documents, is based on data Paradigm clinical program, the project involves 115 cases of severe or moderate to severe patients with type B blood. Clinical data show that the lectin β pegol Connaught B-type blood for sick adults, adolescents, children with routine preventive treatment of bleeding episodes and surgery are very effective, but tolerance, security is good.


Compared with standard coagulation factor IX products, half-promise that lectin β pegol extended five times. In Paradigm clinical projects, despite the promise that thromboxane β pegol administered less frequently, but the patient's blood clotting factors β pegol promise that has reached a higher level: weekly medication 40 IU / kg, promise that coagulation Su β pegol maintained Factor IX activity levels higher than 15%, while the average annual bleeding rate (ABR) was reduced to 1.0, while also showing the potential to prevent the target joint bleeding. In addition, these patients throughout the course of the study the quality of life has also been improved.


Promise that lectin β pegol is a half-life of factor IX product, intended as a replacement therapy for the treatment of B-type blood sick. Glycosylation pegylated is an effective half-life extending technology, and other therapeutic areas A type of blood disease have been proven safe and effective.