To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Refacto Antihemophilic Factor Therapy For Hemophilia A URL: http://www.pslgroup.com/dg/18C116.htm Doctor's Guide March 7, 2000
MADISON, N.J. -- March 7, 2000 -- American Home Products Corporation's ReFacto(R) Antihemophilic Factor (Recombinant), a therapy for hemophilia A, has been approved for marketing by the U.S. Food and Drug Administration (FDA). ReFacto was developed by the Genetics Institute of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products. ReFacto Antihemophilic Factor (Recombinant) is the first recombinant factor VIII product formulated without human serum albumin to be approved by the FDA. ReFacto is indicated for the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. It is the only hemophilia A therapy indicated for short-term routine prophylaxis. "The development of ReFacto reaffirms Genetics Institute's long-term commitment to the hemophilia community and is another example of our ongoing research to bring advanced products to the market place," says Bernard Poussot, President of Wyeth-Ayerst Global Pharmaceuticals. ReFacto is not purified from human blood and contains no preservatives or added human components in the final formulation. Previously, all recombinant factor VIII products added albumin at two production stages: during the cell culture phase when factor VIII cells are grown and during the product's final formulation. While albumin is utilized during the cell culture process for ReFacto, it is not added in the product's final formulation. "Based on efficacy shown in clinical trials, ReFacto represents an important new option for the treatment of people with hemophilia A," says L. Patrick Gage, Ph.D., President, Wyeth-Ayerst Research. "In addition, our recombinant technology and human serum albumin-free formulation offers the potential to reduce the risk of viral contamination for hemophilia A patients." Hemophilia is a genetically inherited blood clotting disorder caused by a deficiency in specialized proteins instrumental in promoting the normal clotting process. Hemophilia A, the most common form of the disorder, is the result of a deficiency in the clotting factor protein referred to as factor VIII. Approximately 17,000 people in the United States are affected by hemophilia A. More than 60,000 infusions of ReFacto have been administered without any reports of viral transmission. ReFacto has been studied in 218 patients (113 previously treated patients, 101 previously untreated patients, and 4 surgical patients) to prevent and control bleeding associated with hemophilia A, representing the largest number of patients to be studied for approval of a hemophilia product to date in the U.S. In clinical trials ReFacto had a safety profile comparable to other factor VIII products. As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. Genetics Institute, a leader in recombinant technology, cloned and developed the first recombinant factor VIII product registered for human use in the U.S. and Europe. It has been used safely for more than 10 years. In 1997, Genetics Institute launched the first recombinant factor IX product, BeneFIX(r) Coagulation Factor IX (Recombinant), which has quickly become the market leader in the treatment of hemophilia B in the United States. Related Links: American Home Products Corporation, Genetics Institute and Wyeth-Ayerst Global Pharmaceutical. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.