Canadians with hemophilia A - a rare, inherited blood-clotting disorder - now have a new treatment option with the introduction of XYNTHA(TM), a recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis.
XYNTHA, developed by Wyeth Pharmaceuticals, now a Pfizer company, is produced using state-of-the-art manufacturing and purification processes designed to reduce the risk of viral contamination. It employs true "next-generation" technology, with completely albumin-free manufacturing from start to finish, purification that is completely free of animal-derived materials, and a virus-capturing nanofiltration step.
"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says François Therrien, Director, Medical Affairs, Specialty Care Business Unit, Pfizer Canada Inc. "XYNTHA provides the highest level of pathogen safety available - patients can trust that every measure is being employed to ensure their safety."
Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists.
The nanofiltration step is an additional safety measure that is unique to XYNTHA. It employs a 35 nanometer pore-size filter that is designed to enhance the viral safety profile and provide added assurance to the hemophilia A community.
"We believe the state-of-the-art manufacturing and purification processes used for XYNTHA make it an exciting new therapeutic option for many Canadians with hemophilia A," says Therrien. "It's the culmination of many years of research and development, and demonstrates our continued commitment to the hemophilia community."
Hemophilia A is characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. People with hemophilia A are deficient in a key protein - factor VIII - that is vital in the clotting mechanism to prevent bleeding. Most patients with hemophilia A are dependent on factor VIII replacement therapy.
Safety and efficacy demonstrated in clinical trials
The safety and efficacy of
XYNTHA in the prevention and control of bleeding episodes and for surgical prophylaxis for patients with hemophilia A has been demonstrated in pivotal clinical trials. The trials looked at previously treated patients who have severe or moderately severe hemophilia A and found that 92.5 per cent of bleeds were treated successfully with 1 or 2 infusions (study included 53 patients) and subjects rated first infusion outcomes as excellent or good (70.6 per cent).
The most common adverse events reported in clinical trials included headache and fever.
Added convenience for patients
XYNTHA is available in four vial sizes, 250IU / 500IU / 1000IU /, and the 2000 IU vial. It is packaged with a one-of-a-kind Rapid Reconstitution (R2) Kit allowing for greater safety, ease of transportation, and fewer steps during rapid reconstitution.