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ReFacto Approved In Europe For Hemophilia A Treatment MADISON, NJ -- April 16, 1999 -- The European Commission has issued marketing authorisation to American Home Products Corp.’s ReFacto (Moroctocog alfa, recombinant factor VIII), an albumin-free formulated recombinant factor VIII product for treatment of hemophilia A. The approval makes available the first recombinant factor VIII product produced without the addition of human serum albumin to the final formulation, providing physicians and patients with unsurpassed safety from contamination by blood-borne pathogens. ReFacto was developed after the largest prospective clinical study program for any hemophilia product -- covering over five years of world-wide clinical use and 36,000 infusions. These studies demonstrated the safety and efficacy of ReFacto in the treatment and prevention of bleeding episodes and in surgery, using comparable dosing with other factor VIII products. "The proven clinical efficacy and safety profile of ReFacto associated with its unsurpassed viral safety characteristics will allow European hemophilia specialists to provide a new option to patients living with hemophilia A," said Christine Lee, professor of hemophilia, Royal Free Hospital, London, and one of the lead investigators in the European trials. During clinical trials, ReFacto had a safety profile comparable to other factor VIII products. As with the intravenous administration of any product, adverse reactions may include headache, fever, chills and flushing. The incidence of inhibitor formation for ReFacto (29 percent in previously untreated patients) was comparable to other factor VIII products. E-mail this page to a friend or colleague! To print, use this version