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| |  Zerit Cleared Under FDA Accelerated Approval Regulations PRINCETON, N.J., -- Jan. 5, 1996 -- Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) today granted full marketing clearance to ZERIT(R) (stavudine, d4T), a nucleoside analogue used in the treatment of human immunodeficiency virus (HIV), the virus that causes AIDS. ZERIT was cleared for marketing under FDA's accelerated approval program on June 27, 1994, based on an interim analysis of data from BMS Study 019, and an analysis of 12,551 patients enrolled in a parallel track study, one of the largest of its kind ever conducted. Bristol-Myers Squibb Company submitted a supplemental New Drug Application to FDA requesting that the indication for ZERIT be expanded to reflect the final results from Study 019. Final analysis included a complete evaluation of clinical endpoints such as the incidence of opportunistic infections and survival. "Bristol-Myers Squibb is proud to be the developer and marketer of the first antiretroviral drug to receive full approval through the FDA's Accelerated Approval process," said Isadore M. Pike, MD, Vice President, Medical at Bristol-Myers Squibb. "We have honored our commitment under FDA accelerated approval regulations to verify the clinical benefit of ZERIT," he added. The approval was based on the results of BMS Study 019, a multi-center, randomized, double-blinded 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. "Our research efforts in developing ZERIT to its fullest potential will not cease," said Laurie Smaldone, MD, Vice President, Infectious Disease, Clinical Research, Bristol-Myers Squibb Pharmaceutical Research Institute. "There are numerous studies, ongoing and planned, to evaluate the role of ZERIT in the treatment of all stages of HIV infection and its role in the initial management of disease in combination with other antiretroviral agents. For example, potentially important data from a combination study utilizing ZERIT will be presented at the upcoming Retrovirus conference in January." ZERIT is indicated for the treatment of adults with HIV infection who have undergone prolonged treatment with AZT. Please see complete prescribing information for ZERIT. Bristol-Myers Squibb Company is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin products. CONTACT: Jennifer True of Bristol-Myers Squibb, 609-252-6540/ (BMY)
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