Drug news
BAX 855 enters Phase II/III study for Haemophilia
Baxter International Inc. has announced it has submitted an Investigational New Drug (IND) application for its investigational Haemophilia A treatment, BAX 855, with the FDA following positive results from a Phase I trial. 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.
Baxter expects to start enrollment of adult patients in its Phase II/III study in the first quarter of 2013. BAX 855 has the potential to maintain the safety profile and meaningfully extend the half-life of Advate to allow for less frequent dosing.