Baxter Healthcare's Advate (Octocog Alfa Recombinant Coagulation Factor VIII) has been granted expanded approval for use in children with haemophilia A under six years of age by the European Commission.
This expanded approval was granted on the basis of interim data from 40 of 53 paediatric patients enrolled in a phase III clinical study. The study was conducted in 23 haemophilia treatment centres 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.
The interim results showed an excellent/good bleed control response rate in 92.4 per cent of the treatments, and a fair rating in 7.6 per cent. No adverse events were deemed related to the study drug and no inhibitors were reported over a median of 74.0 exposure days. No patient has withdrawn from the study due to an adverse event, the company release said.
"The inclusion of children less than six years of age, whether previously treated with FVIII concentrate or not, to the Advate label is an important step forward giving the paediatric patient population access to the only available plasma/ albumin-free FVIII therapy," Hartwig Gajek, medical director in Europe for Baxter's BioScience business said adding, "Now, parents and their children can have reassurance that they are receiving a therapy that virtually eliminates the risk of infection from viruses and infectious prions that may be carried in plasma protein additives."
Advate is the first and only factor VIII concentrate made without the addition of any human or animal plasma proteins, such as albumin, in the cell culture process, purification and final formulation, thereby eliminating the risk of infection from viruses and infectious prions that may be carried in these plasma protein additives.