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| |  VIRAMUNE Receives Accelerated Approval To Treat AIDS ROCKVILLE, Md., June 24, 1996-- The Food and Drug Administration (FDA) today announced that it has granted accelerated approval for VIRAMUNE(R) (nevirapine) for use in combination with nucleoside analogues for the treatment of HIV infected adults who have experienced clinical and/or immunologic deterioration. VIRAMUNE(R) is the first member of the non-nucleoside reverse transcriptase inhibitor class of compounds, which has a different mechanism of action and a distinct side effect profile than currently marketed agents. Boehringer Ingelheim Pharmaceuticals, Inc. filed its new drug application (NDA) with the FDA on February 23, 1996. VIRAMUNE(R) is expected to be available by August. "We have much to learn about the most effective combination therapies. VIRAMUNE(R) adds a new option to combination therapy and provides physicians with the first of a new class of drugs to treat HIV infection," said Dr. Maureen Myers, Clinical Program Director, Virology, at Boehringer Ingelheim Pharmaceuticals, Inc. Accelerated approval is a regulatory mechanism which allows the FDA to grant early marketing status for a product based on laboratory markers such as CD4 cell counts (a reflection of immune system strength) rather than on clinical endpoints such as disease progression. Clinical benefit must eventually be demonstrated for products receiving accelerated approval. Trials designed to demonstrate the clinical benefit of VIRAMUNE(R) in combination with other antiretrovirals are ongoing. VIRAMUNE(R) has been studied in humans since 1991. Clearance by the FDA for VIRAMUNE(R) was based primarily on data from two major clinical trials enrolling 549 HIV-infected adults. The first study, ACTG 241, was a randomized, double blind, placebo- controlled trial, in which 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(R) 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(R) increased CD4 cell count significantly more than the AZT, ddI and placebo combination. In a substudy of ACTG 241, viral load was measured. In these patients the combination of AZT, ddI and VIRAMUNE(R) 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 study, BI 1046, an international randomized, double-blind, placebo-controlled trial, investigated VIRAMUNE(R) in previously untreated patients. The six month results from this twelve month study were recently reported. The study compared the combinations of AZT, ddI and VIRAMUNE(R); AZT and ddI; and AZT and VIRAMUNE(R) in 151 HIV-1 infected patients with entry CD4 counts between 200 and 600. Patients randomized to AZT plus ddI plus VIRAMUNE(R) as well as those receiving AZT plus ddI had improvements in CD4 counts through 24 weeks which remained significantly above baseline; however there was no significant difference between these arms. The triple drug regimen containing VIRAMUNE(R) decreased the viral load below the limit of detection in over 70 percent of the patients, which was significantly greater than either double therapy regimen. Twelve month data is currently being analyzed. At present, there are no results from controlled clinical trials evaluating the effects of VIRAMUNE(R) with nucleoside analogues on the clinical progression of HIV-1 infection, such as the incidence of opportunistic infections or survival. The major clinical toxicity of VIRAMUNE(R) is rash, with VIRAMUNE(R) attributable rash occurring in 17% of patients in combination regimens in controlled studies. Severe and life-threatening skin reactions have occurred in patients treated with VIRAMUNE(R) including Stevens-Johnson syndrome (SJS). Overall, severe rash occurred in 7.6% of VIRAMUNE(R) patients versus 1.2% of controls. Patients who develop severe rash usually do so within the first 28 days. A lead-in dose of one 200 mg tablet per day for two weeks has been shown to reduce the incidence of rash. The standard maintenance dose is one 200 mg tablet taken twice a day. Other common adverse events were fever, nausea, headache, and increases in liver enzymes. Since March of this year, the drug has been available to patients through an expanded access program, which allows access to promising drugs for serious diseases prior to marketing approval. There will be a transition period for those patients enrolled in the expanded access program. The company shortly will announce plans for a reimbursement assistance program. VIRAMUNE(R) 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 introduction of VIRAMUNE(R). 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.
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