EMEA OKs BeneFix modifications
US drug major Wyeth says it has received approval from the European Medicines Agency (EMEA) for enhancements of its BeneFix nonacog alfa (recombinant coagulation Factor IX) product. The drug, which is used in the prophylactic treatment of hemophilia B, will be modified to provide a more convenient preparation process.
The EMEA has cleared a new 2000 IU dosage vial of BeneFix, which Wyeth said will allow patients to use fewer to achieve the desired dosage. In addition, the product will be provided with a pre-filled diluent syringe that is suitable for all dosage strengths, which may reduce the overall volume required for infusion. Finally, a needle less reconstitution device will be provided to eliminate the risk of needlestick injuries.
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