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| |  Data Submitted for Norvir in the Treatment of Children with HIV and AIDS ABBOTT PARK, Ill., Jan. 23, 1997 -- Abbott Laboratories (NYSE: ABT) has submitted to the Food and Drug Administration (FDA) a label recommendation for the use of Norvir in the treatment of children with HIV and AIDS. "We are pleased to be able to take what we learned from the rapid development of Norvir in adults and apply it to the treatment of children," says Andre Pernet, Ph.D., vice president of pharmaceutical products research and development at Abbott Laboratories. "As a result, we were able to seek pediatric use of Norvir very quickly." The data supporting this submission are from an ongoing Phase I/II pediatric study being conducted by a team of scientists at the HIV and AIDS Malignancy Branch of the National Cancer Institute in collaboration with Abbott Laboratories. Interim results from the study indicate that Norvir can increase patients' CD4 cell counts and can decrease the amount of HIV circulating in the blood (plasma HIV RNA). In the study, researchers are examining HIV-infected children with either no prior therapy, progressive disease, or toxicity to another antiretroviral regimen. Four dose levels of a liquid formulation, ranging from 250 milligrams/m2 to 400 milligrams/m2, were given orally, twice daily, and evaluated in two age groups: children under age two and children two and older. Norvir was given alone for the first 12 weeks, then in combination with zidovudine and/or didanosine. Medications contraindicated for use with Norvir were prohibited. Forty-four patients have completed at least four weeks of study and were included in the submission. Two additional patients who had not yet reached four weeks of study were not included in the submission. By week eight of monotherapy, the CD4 count had increased by a mean of 51 to 132 cells per cubic millimeter in the children across the four dose levels. Plasma HIV RNA levels decreased rapidly from baseline by more than 90 percent by four weeks and the mean change remained below baseline at 24 weeks. In the study, the most common adverse events attributed to Norvir were diarrhea (60%), vomiting (48%), and abdominal pain (45%). Three patients discontinued due to elevated liver enzymes and six patients discontinued due to gastrointestinal symptoms or fatigue. These data supporting Abbott's submission to the FDA will be presented on Jan. 25, 1997, at the 4th Conference on Retroviruses and Opportunistic Infections, in Washington, D.C. Norvir is currently indicated in combination with nucleoside analogues or as monotherapy for the treatment of HIV-infection when therapy is warranted. For patients with advanced HIV disease, this indication is based on the results from a study that showed a reduction in both mortality and AIDS-defining clinical events for patients who received Norvir. Median duration of follow-up in this study was six months. The clinical benefit from Norvir therapy for longer periods of treatment is unknown. For patients with less advanced disease, this indication is based on changes in surrogate markers in studies evaluating patients who received Norvir alone or in combination with other antiretroviral agents. Abbott Laboratories is a diversified, global health care company devoted to the discovery, development, manufacture, and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 52,000 people and markets its products in more than 130 countries.
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