Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE
In addition, it had a longer half-life than Advate
, which could potentially reduce the frequency of injections needed by hemophilia patients.
BAX 855 is a full-length longer-acting recombinant factor VIII (rFVIII) that was developed to increase the half-life of ADVATE
[Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] - the most widely chosen rFVIII in the world.
This growth was driven by record sales of ADVATE
, Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of hemophilia A, antibody therapy products, including GAMMAGARD LIQUID(TM) [Immune Globulin Intravenous (Human)] (IVIG) 10% Solution for the treatment of primary immunodeficiencies, specialty plasma therapeutics and biosurgery products.
The study was conducted in 23 haemophilia treatment centers in Europe and the United States, and assessed the pharmacokinetics, safety, efficacy and immunogenicity of ADVATE
in previously treated haemophilia A patients less than six years of age.
With our focus on the needs of the hemophilia patient community, Baxter screened more than 100 molecules over several years and has selected one that has the potential to maintain the safety profile and meaningfully extend the half-life of ADVATE
to allow for less frequent dosing.
Upon approval, BAX 855 will offer patients a twice-weekly dosing option with proven efficacy based on ADVATE
, a leading standard of care for hemophilia
Contract award: medicinal products - feiba and advate
In the United States and Canada, Baxter also launched Baxject II, a needleless transfer device with built-in filters for Advate
Sales growth in this business was driven by a 15 percent increase in the recombinant business, including $162 million of sales of ADVATE
, Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of hemophilia A.
Secondary endpoints included response to treatment of bleeding episodes and the pharmacokinetics of rFVIIIFc versus Advate
With more than a decade of experience with ADVATE
and an extensive global presence, our BAX 855 program represents our continued commitment to supporting the hemophilia community, particularly this week as we celebrate World Hemophilia Day with our colleagues around the globe.
Contract notice: Medicinal products - feiba and advate
This was primarily the result of robust growth in demand for ADVATE
[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)], and other plasma-based therapeutics including FEIBA, an inhibitor bypass therapy, and products to treat hereditary emphysema.
Our goal with BAX 855 is to extend the interval between infusions while maintaining a similar efficacy profile to ADVATE
," said John Orloff, M.