ZURICH, Switzerland, Dec. 23 /PRNewswire-FirstCall/ -- Baxter Healthcare S.A. announced today that the European Commission has granted expanded approval of ADVATE(R) (Octocog Alfa Recombinant Coagulation Factor VIII), for use in children with haemophilia A under six years of age.
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 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.
The interim results showed an excellent/good bleed control response rate in 92.4 percent of the treatments, and a fair rating in 7.6 percent. 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 No patient has withdrawn from the study due to an adverse event.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 safety and efficacy profile of ADVATE in children and adults are comparable, with slightly different pharmacokinetic properties in adults, but with similar bleed control response ratings, a low incidence of drug-related adverse events and low inhibitor risk in previously treated patients. These data suggest that ADVATE is efficacious and well-tolerated for the prevention and treatment of bleeding episodes in previously treated paediatric patients with haemophilia A.
"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 pediatric patient population access to the only available plasma/ albumin-free FVIII therapy," said Hartwig Gajek, MD, medical director in Europe for Baxter's BioScience business. "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.
ADVATE was initially approved by the European Commission in March 2004. The availability of ADVATE in other countries varies based on the timing of similar reimbursement approvals. ADVATE is currently reimbursed in Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Sweden, Switzerland and the United Kingdom.
ADVATE is a blood clotting therapy that helps people with haemophilia A prevent and control bleeding episodes. Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body's blood clotting process to function properly.
ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of Factor VIII preparations or known sensitivity to mouse or hamster proteins. The most common related adverse events observed during the ADVATE clinical studies included: strange taste in mouth, headache, dizziness and flushing.
More information, including U.S. full prescribing information for ADVATE, is available at http://www.advate.com/ .
ABOUT HAEMOPHILIA A
People with haemophilia A do not produce adequate amounts of factor VIII, which is necessary to effectively stop bleeding. Without enough factor VIII, patients can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating and damaging to joints. If untreated, patients with severe haemophilia A may have a greatly reduced life expectancy.
Baxter Healthcare S.A. is the principal European operating subsidiary of Baxter International Inc. Baxter International Inc. , through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
Baxter Healthcare S.A.