Wyeth reports EMEA approval for BeneFix enhancements

Wyeth Pharmaceuticals, a subsidiary of Wyeth, has announced that it has received marketing approval from the European Medicines Agency (EMEA) for new enhancements for BeneFix (nonacog alpha).

The improvements to the company’s recombinant coagulation factor IX seek to provide patients with a more convenient and simpler preparation process when compared to that previously required for the drug.

Enhancements include a 2000 IS dosage strength vial, a prefilled diluent syring, a 5 ml diluent volume for all dosage strengths and a needleless reconstitution device.

As a result of these improvements, patients will be able to use fewer vials to achieve their desired dosage, with speedier preparation from fewer components and reduced risk of needlesticks during reconstitution.

Gary L Stiles, executive vice-president and chief medical officer, said: “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.”

This announcement follows Wyeth’s assumption of distribution and marketing rights to BeneFix in Europe following the close of a ten-year distribution rights agreement between Baxter Healthcare and Genetics Institute – a firm acquired by Wyeth in 1996.

On acquiring these rights to BenFix, Wyeth reported cooperation between the partners to ensure a smooth transition of responsibility and uninterrupted supply of the drug to haemophilia patients in Europe.