Congenital hypofibrinogenemia

National Hemophilia Foundation Revises Treatment Guidelines for Factor 1 Deficiency to Include Octapharma’s fibryga®

Retrieved on: 
Wednesday, October 7, 2020

The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.

Key Points: 
  • The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.
  • View the full release here: https://www.businesswire.com/news/home/20201007005220/en/
    The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.
  • We are committed to providing life-saving treatment options to people with rare bleeding disorders, including Factor 1 deficiency.
  • Fibrinogen replacement therapies for Factor 1 deficiency include fibrinogen concentrates or cryoprecipitate.

DGAP-News: Biotest AG: Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen

Retrieved on: 
Tuesday, May 26, 2020

In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery.

Key Points: 
  • In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery.
  • These patients are unable to produce functional fibrinogen themselves, or only insufficiently and are therefore dependent on the administration of external fibrinogen.
  • The prospective, open, multicentre phase I/III study investigated the pharmacokinetic properties, efficacy and safety of fibrinogen concentrate in adults and children with congenital fibrinogen deficiency.
  • Biotest is also testing the fibrinogen concentrate in this indication in the phase III trial called "ADFIRST".

Octapharma USA Sponsors ASA Symposium on Fibrinogen Supplementation in Surgical Patients

Retrieved on: 
Tuesday, November 5, 2019

Octapharma USA sponsored a scientific symposium, Fibrinogen Supplementation in Surgical Patients New Perspectives in Acquired Fibrinogen Deficiency, at the recent American Society of Anesthesiologists Annual Meeting.

Key Points: 
  • Octapharma USA sponsored a scientific symposium, Fibrinogen Supplementation in Surgical Patients New Perspectives in Acquired Fibrinogen Deficiency, at the recent American Society of Anesthesiologists Annual Meeting.
  • The symposium addressed the global perspectives on patient blood management with respect to fibrinogen replacement in acquired bleeding and treatment options for acquired fibrinogen deficiency (AFD).
  • The studies presented at the symposium are important contributions to build on the current published research and growing clinical experiences with fibrinogen concentrates for managing bleeding in surgical patients, said Jerrold Levy, M.D.
  • These two important clinical trials investigating the use of fibryga in acquired fibrinogen deficiency have identified fibrinogen concentrate as a potential alternative to cryoprecipitate during severe surgical bleeding, said Octapharma USA President Flemming Nielsen.

Octapharma’s fibryga® Receives European Label Extension to Treat Acquired Fibrinogen Deficiency (AFD)

Retrieved on: 
Tuesday, November 5, 2019

Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries.

Key Points: 
  • Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries.
  • The approval extends the market authorisation for fibryga, which is already approved for use in patients with congenital fibrinogen deficiency.
  • Fibryga is a highly purified, dual pathogen-inactivated, lyophilised human fibrinogen concentrate for intravenous infusion, with a rapid, convenient reconstitution device for effective correction of fibrinogen deficiency.
  • However, patients treated with fibryga experienced more rapid and pronounced replenishment of plasma fibrinogen levels and blood clot firmness.