Vertex, Glaxo file for FDA approval of investigational protease inhibitor
BY Advocate.com Editors
December 24 2002 1:00 AM ET
Officials from pharmaceutical companies GlaxoSmithKline and Vertex Pharmaceuticals Inc. announced Friday that they have filed a new drug application with the Food and Drug Administration for their investigational, second-generation protease inhibitor known as GW433908 or simply 908. The companies also filed on the same day for European Union approval of the drug.
The submissions include data from more than 1,100 patients who have participated in Phase III trials to evaluate the safety and efficacy of 908 in comparison with two widely used HIV protease inhibitors. In clinical trials, 908 was shown to reduce HIV viral loads to undetectable levels in about 70% of previously untreated HIV-positive adults with advanced HIV disease. The companies, which jointly developed the drug, hope to have it approved for marketing in the United States by the second half of 2003.