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| |  VIRAMUNE Recommended for Accelerated Approval for HIV Infection Silver Spring, MD -- June 10, 1996 -- The Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) on Friday voted to recommend that the agency grant accelerated approval for VIRAMUNE® (nevirapine) in combination with nucleoside analogues for treating human immunodeficiency virus (HIV) infection. This decision is based on the results from several trials submitted to the FDA as part of a new drug application. The Committee's recommendation for accelerated approval of VIRAMUNE® paves the way for the FDA to consider the introduction of a new class of drugs to treat HIV infection. The two approved classes are nucleosides analogues, such as AZT and protease inhibitors. VIRAMUNE® is a non-nucleoside reverse transcriptase inhibitor (NNRTI), which has a different mechanism of action and a distinct side effect profile from other classes of currently approved antiretrovirals. While the nucleoside analogues prevent the growth of the DNA chain, non-nucleoside drugs directly inactivate the enzyme. "We are pleased by the Committee's recommendation because the availability of VIRAMUNE®, in combination with nucleoside analogues, offers a promising new treatment option in the fight against AIDS," said Dr. Maureen Myers, Clinical Program Director, Virology, at Boehringer Ingelheim Pharmaceuticals, Inc. In the first major study presented, ACTG 241, a randomized, double blind, placebo controlled trial, researchers followed 398 patients for 48 weeks at 16 participating investigational sites. All patients entering the study had advanced HIV infection with CD4 cell counts of less than or equal to 350 (mean CD4 cell count for these patients was 153). The study compared the combination of AZT, ddI and VIRAMUNE® to the combination of AZT, ddI and placebo. Patients in this trial had received extensive prior nucleoside therapy. The ACTG 241 study found that the combination of AZT, ddI and VIRAMUNE® increased CD4 cell count significantly more than AZT, ddI and placebo combination. In a substudy, viral markers were followed. In these patients the combination of AZT, ddI and VIRAMUNE®, reduced the viral load significantly more than AZT, ddI and placebo, throughout the 48 weeks of the trial. The clinical significance of changes in viral RNA has not been established. The second major study presented, BI 1046, an international randomized, double blind, placebo controlled trial, investigated VIRAMUNE® in previously untreated patients. The six month results from this twelve month study compared the combinations of AZT, ddI and VIRAMUNE®; AZT and ddI; and VIRAMUNE® and AZT in 151 HIV-1 infected patients with CD4 counts between 200 and 600. Changes in CD4 counts through 28 weeks: levels of CD4 in those randomized to AZT plus ddI plus VIRAMUNE® and AZT plus ddI remained significantly above baseline; however there was no significant difference between these arms. The triple drug regimen containing VIRAMUNE® decreased the viral load below the limit of detection in about two-thirds of the patients, which was significantly greater than either double therapy regimen. In controlled clinical trials the most common VIRAMUNE® side effect was rash, which in 7.6% of patients was considered severe. Increases in the liver enzymes occurred in 5-10% of patients compared with 2-5% in controls. No data are available on disease progression or survival, however clinical endpoint studies are underway. VIRAMUNE® is a product of original research at Boehringer Ingelheim Pharmaceuticals, Inc, located in Ridgefield, CT. In addition to Boehringer Ingelheim Pharmaceuticals, two other affiliate companies of Boehringer Ingelheim Corporation (Ridgefield, CT) -- BI Chemicals, Inc. (Petersburg, VA) and Roxane Laboratories, Inc. (Columbus, OH) -- are collaborating in the development of VIRAMUNE®. This collaboration capitalizes on Boehringer Ingelheim Pharmaceuticals' extensive development and clinical capabilities, BI Chemicals' strength in the production of fine chemical substances, and Roxane Laboratories' experience in the HIV/AIDS arena. Boehringer Ingelheim Corporation is a member of the Boehringer Ingelheim worldwide group of companies, based in Ingelheim, Germany. A privately-held company founded in 1885, Boehringer Ingelheim is a major pharmaceutical, chemical, animal health, and bakery products manufacturer with operations in more than 100 countries around the world. For more information, please contact either Pam DeMala (203-798-4700) or Ryan Peal (202-944-5163; rpeal@hillandknowlton.com).
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