Wyeth Pharmaceuticals
This article was originally published in The Gray Sheet
Executive Summary
ReFacto R2 kit for recombinant antihemophilic factor VIII delivery, cleared via biologics license application supplement Sept. 10, provides the first available needleless reconstitution process for powdered factor VIII and a pre-filled diluent component for hemophilia treatment, the firm says. Eliminating two of the three needles used in Wyeth's previous ReFacto delivery kit, which was not pre-filled, the revised version incorporates a syringe made by Vetter, a vial adapter manufactured by Medimop and Braun infusion components. Priced the same as the earlier version, the next generation kit adds convenience, takes less time to use and will facilitate competition with factor VIII firm Baxter, Wyeth notes. A fourth quarter launch is anticipated...