To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Expanded labelling requested for Zerit URL: http://www.pslgroup.com/dg/5C1A.htm Doctor's Guide August 1, 1995
PRINCETON, N.J. - Press release August 1, 1995 - Bristol-Myers Squibb Company (NYSE: BMY) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration requesting that the indication for ZERIT(TM) (stavudine, d4T) be expanded to reflect recent clinical findings. The request for expanded labeling is based on positive final results of Bristol-Myers Squibb (BMS) study 019, a multi-center, randomized, double-blind trial of ZERIT vs. continued AZT (zidovudine) in 822 HIV- infected adults with CD4 cell counts between 50 and 500 cells/mm(superscript 3) and at least 24 weeks of prior AZT treatment. Final analysis of the study includes a complete evaluation of clinical endpoints such as the incidence of opportunistic infections and survival. ZERIT is currently indicated for the treatment of adults with advanced HIV infection who are intolerant to approved therapies with proven clinical benefit or who have experienced significant clinical or immunologic deterioration while receiving these therapies, or for whom such therapies are contraindicated. ZERIT was cleared for marketing under FDA s accelerated approval program on June 27, 1994 based on an interim analysis, conducted at 12 weeks, of data from BMS study 019, and an analysis of 12,551 patients enrolled in the Parallel Track study. Completion of these studies represents a commitment by Bristol-Myers Squibb to verify the clinical benefit of ZERIT as mandated by accelerated approval regulations, and to conduct meaningful research to improve the care of persons with HIV disease. ZERIT belongs to the nucleoside analogue family of compounds that includes VIDEX(R) (didanosine, ddI), which was cleared for marketing by FDA in October 1991 and has been marketed by Bristol-Myers Squibb since that time. In addition to ZERIT and VIDEX, the Bristol-Myers Squibb HIV-related products portfolio includes Megace(R) (megestrol acetate) Oral Suspension. Bristol-Myers Squibb is a diversified health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is among the world's leading makers of cardiovascular, anti-cancer, anti-infective, central nervous system and dermatological drug therapies, nonprescription medicines, orthopaedic devices, ostomy and wound care management, specialized nutritional and personal care products. CONTACT: Robert F. Laverty of Bristol-Myers Squibb, 609-252-5551 (BMY) --------------------------------------------------------------------------------------------- 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.