Baxter Healthcare S.A. announced that the French Transparency Commission has issued a positive opinion to grant reimbursement status for Advate (Octocog Alfa Recombinant Coagulation Factor VIII). This approval represents the last step in making this product available to patients within France by putting it on the list of therapies that are reimbursed by the National Health Insurance.
"We are pleased to have received this positive decision from the French regulatory authorities that allows patients access to an important new therapy in France for haemophilia A," said Hartwig Gajek, medical director in Europe for Baxter's BioScience business.
Advate is the first and only factor VIII 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 approved by the European Commission in March 2004. It 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.