Introduction: Nonacog beta pegol (N9-GP) is a glycoPEGylated recombinant factor IX (FIX) with an extended half-life developed for routine prophylaxis and the prevention and treatment of bleeding episodes in patients with haemophilia B.
Novo Nordisk has announced the submission to the FDA of the Biologics License Application for the approval of long-acting factor...
Novo Nordisk has announced the submission to the European Medicines Agency of the Marketing Authorisation Application for the approval of...
Background: Nonacog beta pegol is a recombinant glycoPEGylated factor IX with an extended half-life, developed to improve care for patients with hemophilia B.
Pfizer Inc. announced the publication of the Phase III study results of a once-weekly regimen of BeneFIX Coagulation Factor IX...
Pfizer announced the positive results of a Phase III study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX (Recombinant)...
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation...
Sobi and Sanofi announced that the XTEND-Kids phase III pivotal study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa as once-weekly prophylaxis in previously treated patients under 12 years of age with severe haemophilia A met its primary endpoint
Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi announced positive top-line results from the pivotal XTEND-1 phase III study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients greater than 12 years of age with severe haemophilia A.
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). BeneFIX can be used for all age groups.