Wyeth Pharmaceuticals, a division of Wyeth, has received approval from the European Medicines Agency (EMEA) for new enhancements for BeneFIX nonacog alfa (Recombinant Coagulation Factor IX). These enhancements are designed to offer patients a simpler and more convenient preparation process compared with the original BeneFIX preparation process.
The convenience enhancements for BeneFIX include: A 2000 IU dosage strength vial. This is now the largest unit dosage vial offered for haemophilia B treatment. As a result, many patients will be able to use fewer vials of BeneFIX to achieve their desired dosage; A prefilled diluent syringe. This feature allows for fewer components and faster preparation compared to the original BeneFIX preparation process; A 5 ml diluent volume for all dosage strengths, which may decrease the overall volume of product required for infusion; A needleless reconstitution device, which eliminates the risk of needlesticks during reconstitution.
"Each of these new features was designed to enable BeneFIX patients to spend less time preparing their factor product, to prepare it more safely and to have additional time for themselves," says Gary L. Stiles, M.D., executive vice president and chief medical officer, Wyeth Pharmaceuticals.
Recently, Wyeth announced that it has assumed all marketing and distribution rights to BeneFIX in Europe following the planned June 30, 2007, conclusion of a 10-year distribution rights agreement between Baxter Healthcare Corporation and Genetics Institute. Genetics Institute was acquired by Wyeth in 1996. Wyeth manufactures and markets recombinant products for both haemophilia A and B patients.
BeneFIX is a coagulation factor that uses a recombinant DNA technology to produce clotting factor IX, which stops or prevents bleeding in people with haemophilia B who do not have enough factor IX of their own. BeneFIX is a recombinant product and it is inherently free from the risk of transmission of human blood-borne pathogens, such as HIV, hepatitis viruses and parvovirus.
Haemophilia B is a rare, inherited blood-clotting disorder. People with haemophilia B are deficient in a key protein - factor IX - which is vital in the clotting mechanism to prevent bleeding. Haemophilia B is characterized by spontaneous haemorrhages or prolonged bleeding, typically into joints and soft tissue. Most patients with haemophilia B are dependent on replacement therapy with factor IX.
BeneFIX is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).