FDA News

FDA approves Hemophilia drug

(March 26, 2007)--Wyeth Pharmaceuticals said that it has received approval from the U.S. Food and Drug Administration (FDA) for new product enhancements for BeneFIX(R) 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 hemophilia 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.

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.

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.

With the recent FDA approval, the final infusion volume for BeneFIX could be reduced by up to 75 percent 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 hemophilia B therapies when similar IU amounts are infused.

Because many individuals require infusions of greater than 2000 IU per dose, patients often are required to use several vials at a time. With the introduction of the 2000 IU dosage strength vial for BeneFIX, many patients will be able to use fewer vials of BeneFIX to achieve their desired dosage, allowing for easier and faster preparation compared with the original BeneFIX preparation process. In addition, the 2000 IU vial is expected to be useful in the surgical setting, which often requires higher doses of hemophilia treatments. The BeneFIX 2000 IU dosage strength vial will be the largest unit dosage vial offered for hemophilia B treatment.

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