To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Orphan Drug Status To Thymoglobulin (Anti-Thymocyte Globulin) For Myelodysplastic Syndrome URL: http://www.pslgroup.com/dg/1E18EE.htm Doctor's Guide September 19, 2000
FREMONT, CA -- September 19, 2000 -- SangStat, The Transplant Company® announced that Thymoglobulin® (Anti-thymocyte Globulin, (Rabbit)) has been granted orphan drug designation for the treatment of Myelodysplastic Syndrome (MDS) by the U.S. Food and Drug Administration (FDA). Thymoglobulin is marketed by SangStat Medical Corporation in both the US and Europe and is the number one immunosuppressive antibody worldwide according to IMS data. Over 40,000 patients in 54 countries have been treated with Thymoglobulin. MDS, also referred to as pre-leukemia, is a disease in which the bone marrow does not function normally and not enough normal blood cells are made. An estimated 30,000 to 40,000 people in the United States suffer from MDS. Approximately 40 percent of patients will die from the consequences of ineffective blood cell production and 30 percent will progress to develop acute leukemia, a form of cancer where too many white blood cells are made. Supportive care with transfusions remains the principal therapy for less advanced types of MDS. Current treatments for the advanced types of the disease include chemotherapy and/or bone marrow transplantation, however these are ineffective or not available in the majority of cases. Orphan drug designation is granted to applicants when the prevalence of the disease occurs in less than 200,000 patients in the United States. The advantages of this designation include a waiver of the user fee, possible marketing exclusivity and tax credits for development costs. These advantages are intended to encourage sponsors to develop drugs for patients with rare diseases. SangStat submitted the Orphan Drug Designation Application for Thymoglobulin on May 5th 2000. "Based on preliminary European data with Thymoglobulin for MDS, we hope that the ongoing US clinical trial will demonstrate that Thymoglobulin may be a safe and effective treatment for patients with MDS," said Dr. Elizabeth Squiers, Senior Director Acute Care Therapeutics at SangStat and the Clinical Development lead in this trial. Despite recent advances in immunosuppressive agents, from 20 percent to 60 percent of the 12,000 US patients who receive kidney transplants each year experience acute rejection during the first year following transplantation. Acute rejection can often lead to the loss of the transplanted organ. Thymoglobulin (anti-thymocyte globulin (rabbit)) was introduced to the US market in 1999 for the treatment of renal transplant acute rejection, and according to IMS data has since captured the top spot in US immunosuppressive antibody therapies. Thymoglobulin is a pasteurized anti-thymocyte rabbit immunoglobulin indicated for the treatment of renal transplant acute rejection, in conjunction with concomitant immunosuppression. Common adverse reactions, which are often transient, include fever, infections, and thrombocytopenia. Thymoglobulin is contraindicated in patients with known allergy to rabbit proteins, an acute viral illness, or a history of anaphylaxis during rabbit immunoglobulin administration. Thymoglobulin should only be used by physicians experienced in immunosuppressive therapy in the management of renal transplant patients. --------------------------------------------------------------------------------------------- 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.