Wyeth Pharmaceuticals announced the results of a study demonstrating the comparability
of its recombinant factor VIII (rFVIII) drug, ReFacto®, with another rFVIII product, Baxter's Advate®. Both products are indicated for the prevention and control of bleeding episodes associated with hemophilia A.
The study examined the pharmacokinetics (the interaction between the body and a drug) of both products in 17 patients at eight sites. The participants were all previously treated patients. They first underwent a three day "washout period" during which they received no treatment. After that, each patient was randomly selected to receive a single infusion of either ReFacto® or Advate®. Following a second washout period, patients were treated with the alternate product. Results yielded from blood samples taken before and after the infusions showed that the products are bioequivalent--therapeutically comparable and with a similar clinical effect on the body.
"Due to the limited number of studies comparing products, healthcare professionals and patients often rely on anecdotal reports to gather information on clotting factor products. This study provides 'real-world' data that will help us to make more informed decisions," said Jorge Di Paola, MD, Assistant Professor of Pediatrics and Director of the Hemophilia Treatment Center at the University of Iowa.
Source: Wyeth news release dated May 23, 2006