Wyeth Pharmaceuticals, a division of Wyeth, has received approval from the US Food and Drug Administration (FDA) for new product enhancements for BeneFIX coagulation factor IX (Recombinant) that will offer patients a simpler and more convenient preparation process compared with the original BeneFIX preparation process.
BeneFIX is a coagulation factor created using recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with haemophilia B who do not have enough factor IX of their own.
A new BeneFIX feature allows patients currently using the most common dosage strength 1000 international units (IU) to use a lower volume of diluent to administer the product, leading to a lower total volume of infused product. BeneFIX also offers a new needleless preparation process, eliminating the risk of needlesticks during reconstitution.
"Each of these product enhancements is a first for the treatment of haemophilia B. These new features were 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, executive vice president and chief medical officer, Wyeth Pharmaceuticals.
The FDA approved the following four product enhancements for BeneFIX Coagulation Factor IX a 2000 IU dosage strength vial, a needleless reconstitution device, a prefilled diluent syringe and a reduced diluent volume.
R2 Kit Offers Greater Convenience for Product Preparation Wyeth's needleless reconstitution kit - the BeneFIX R2 Kit - will offer a faster and simpler preparation process compared with the original BeneFIX preparation process, without the risk of needlesticks during reconstitution. With the R2 Kit - R2 stands for rapid reconstitution - the number of steps for preparing an infusion is reduced, and exposure to a needle during the reconstitution process is eliminated. The R2 Kit contains a syringe prefilled with diluent, a vial adapter and a single-use vial of BeneFIX.
Lower Diluent Volume and New Prefilled Syringe Allow Ease of Product Preparation With the recent FDA approval, the final infusion volume for BeneFIX could be reduced by up to 75 per cent for an individual patient.
For some patients, a reduced diluent amount translates to less volume to infuse. This is useful for any patient but particularly those who infuse multiple vials of BeneFIX. With the introduction of the 5 mL prefilled diluent syringe for all dosage strengths, including the new 2000 IU dosage strength vial, BeneFIX will have the lowest infusion volume of haemophilia B therapies when similar IU amounts are infused.
Wyeth expects to begin offering BeneFIX with these new enhancements in mid-2007. BeneFIX is the only recombinant clotting factor product for haemophilia B and inherently is free from the risk of transmission of human blood-borne pathogens, such as HIV, hepatitis viruses and parvovirus.
The development of the new BeneFIX features is one element of Wyeth's commitment to offering advances for haemophilia patients. Recently, the Company announced development partnerships with Nautilus Biotech in Evry, France, and MediVas, LLC, in San Diego, Calif., to develop longer-acting haemophilia therapies.
Haemophilia is a rare, inherited blood clotting disorder, and haemophilia B affects approximately 3,300 people in the United States. People with haemophilia are deficient in one of the key proteins either factor VIII (haemophilia A) or factor IX (haemophilia B) that are vital in the clotting cascade to prevent bleeding