Approval of n9-gp by FDA

Source: on May 31, 2017, Novo Nordisk announced that FDA approved rebinyn (n9-gp) biological product license application (BLA) for the treatment of adult and child hemophilia B Nord Nord plans to list rebinyn in the United States in the first half of 2018 N9-gp is a PEGylated recombinant human clotting factor IX with a longer half-life than that of common recombinant human clotting factor IX it is used in adult and Child B hemophilia patients to control bleeding attack on-demand treatment and perioperative bleeding management Its efficacy and safety have been confirmed in the paradigms project The paradigms project included 115 mild to severe adult and Child B hemophilia patients who had been treated with other drugs These patients were treated with rebinyn for up to 2.7 years, with a total of more than 8800 days of exposure in the drug On March 24 this year, rebinyn was also approved by the European Drug Administration CHMP for on-demand treatment and perioperative bleeding management of adults and adolescents (over 12 years old) Hemophilia B is a chronic and hereditary disease Patients with hemophilia B are characterized by coagulation disorders or bleeding due to the lack of clotting factor IX there are about 5000 patients in the United States.