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BeneFix enhancements get approval


The European Medicines Agency has given approval for a range of enhancements for Wyeth Pharmaceuticals’ BeneFix® (coagulant factor IX (recombinant)), used by people with haemophilia B.

The company has made a number of changes to how the medication is administered, in a bid to make things simpler for patients.

Users will now get a prefilled diluent syringe, which it is hoped will reduce the amount of time they spend preparing their treatment.

A 5ml diluent volume for all dosage strengths will now be available, which the company believes may decrease the overall volume of the drug required for infusion.

And it will also come with a needleless reconstitution device, which it is hoped will eliminate the risk of needlestick injuries suffered during treatment.

Gary Stiles, chief medical officer at Wyeth Pharmaceuticals, 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.”

The company recently announced it has assumed all marketing and distribution rights to BeneFix in Europe following the end of a 10-year distribution rights agreement between Baxter Healthcare and Genetics Institute. Genetics Institute was acquired by Wyeth in 1996.

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Wyeth Pharmaceuticals
European Medicines Agency


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