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| |  FDA Unanimously Recommends Approval of Videx(r) for HIV/AIDS WASHINGTON, Feb. 29, 1996 -- The U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee unanimously recommended that VIDEX(R) (didanosine; ddI) be cleared as a first-line antiretroviral therapy for human immunodeficiency virus (HIV), the virus that causes AIDS. The vote is based on striking new results from three large-scale clinical trials including the AIDS Clinical Trials Group (ACTG) 152 pediatric study, the largest controlled pediatric trial to date, which show that Bristol-Myers Squibb's VIDEX delays progression of AIDS and is superior to AZT (zidovudine) monotherapy. "The results of ACTG 152 will change the way children with HIV infection are treated. VIDEX was significantly better than AZT in preventing disease worsening or death," said Carol Baker, M.D., Professor, Microbiology & Immunology and Pediatrics, Baylor College of Medicine. "Clearly, VIDEX as a single drug was equally effective and found to be safer than the addition of AZT to VIDEX in combination therapy." ACTG 152 compared three treatments for children with symptomatic HIV infection or AIDS: VIDEX taken alone, VIDEX plus AZT and AZT monotherapy. The study found that children who were given VIDEX alone or in combination were less likely to develop serious infections associated with HIV or suffer serious side effects than did those receiving AZT monotherapy. In fact, based upon significant differences seen in disease progression and deaths, the AZT monotherapy portion of the trial was prematurely discontinued by the ACTG. Children receiving VIDEX alone or in combination with AZT were allowed to complete the study. The children who received VIDEX alone and those who received AZT in combination with VIDEX benefited similarly from the therapy. Also presented were two additional studies that showed the same results in adults which further demonstrate the survival benefit of VIDEX: the European and Australian Delta Trial and U.S. ACTG 175 trial, which together studied over 5,000 patients. The ACTG 175 study found that VIDEX, alone or in combination with AZT, was superior to AZT monotherapy in slowing CD4 cell decline, or delaying progression to AIDS and death. The results of the Delta Trial were consistent with the results of ACTG 175, although the patients in the Delta Trial entered with more advanced disease than those patients in ACTG 175. "The results of ACTG 175 are extremely important and will change the way that HIV-infected adults are initially treated," said Martin Hirsch, M.D., Professor of Medicine, Harvard University. "ddI (VIDEX), either as monotherapy or in combination with AZT, was superior to AZT monotherapy in substantially reducing the risk of disease progression among patients with intermediate stage disease." The Delta Trial showed that VIDEX plus AZT significantly prolonged survival compared to AZT monotherapy in patients with more advanced HIV infection just starting therapy. In these patients, the combination of VIDEX plus AZT significantly reduced the risk of death by 42%, which is superior to AZT monotherapy. In addition, VIDEX plus AZT significantly slowed progression to AIDS or death as compared to AZT plus ddC (zalcitabine). "The proven survival benefit of VIDEX shows that the drug can be considered an important component of future combinations, including those with the protease inhibitors," said Paul A. Volberding, M.D., Director, AIDS Program, University of California, San Francisco. "We are extremely gratified by the FDA Antiviral Drugs Advisory Committee recommendation," said Laurie Smaldone, M.D., Vice President, Infectious Disease, Clinical Research, Bristol-Myers Squibb Pharmaceutical Research Institute. "The data clearly indicate that front-line treatment with VIDEX-based therapies significantly benefits patients with HIV. Both VIDEX and the combination of VIDEX and AZT have proven their survival benefit and should assume an important role as initial therapy for the treatment of HIV infection." VIDEX belongs to the nucleoside analogue family of compounds, which also includes Bristol-Myers Squibb's ZERIT(R) (stavudine; d4T). "Interim results of another study, AI 460-001, show that the combination of VIDEX and ZERIT dramatically reduces the amount of virus in the blood. Preliminary data recently presented suggest the combination of VIDEX plus ZERIT may be one of the most potent and long lasting of the nucleoside combinations. Although there have been no direct comparisons, the combination of VIDEX plus ZERIT may surpass the effects reported for other combination therapies," said Dr. Smaldone. "In addition to its proven clinical benefit, VIDEX therapy is significantly less expensive," said Michael Loberg, Ph.D., President, Bristol-Myers Squibb Oncology/Immunology. "The annual cost of VIDEX is significantly less than all the other antiretroviral drugs, including AZT. As the increasing use of multiple-drug combination therapies raises the overall cost of treating HIV, this advantage is becoming more important to the patient and the health care provider," he added. In response to patient requests, VIDEX will soon be available as a smaller tablet which is easier to chew, quicker to dissolve in water, and orange flavored. These improvements are expected to further increase the use of VIDEX by both patients with HIV and the physicians who care for them. The new tablets were cleared by the FDA earlier this week. In ACTG 175 and the Delta Trial, therapy with VIDEX was well tolerated and clinical adverse events such as pancreatitis were rare in all treatment regimens. VIDEX is currently indicated for the treatment of adults and children with advanced HIV infection and prolonged prior treatment with AZT, or for those who are intolerant of or failing AZT therapy. ZERIT, which has been marketed in the U.S. since 1994, is available in other countries and has been recommended for marketing approval in the fifteen countries of the European Union. ZERIT is indicated for the treatment of HIV-infected adults who have received prolonged prior zidovudine therapy. Please see complete prescribing information for VIDEX and ZERIT. Bristol-Myers Squibb 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, orthopedic 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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