Glaxo plans to file for approval of second-generation protease inhibitor
BY Advocate.com Editors
November 26 2002 1:00 AM ET
Officials from drugmaker GlaxoSmithKline on Sunday announced that the company will file for Food and Drug Administration approval of its second-generation protease inhibitor, known as 908, by the end of the year. Developed jointly with Vertex Pharmaceuticals, 908 has been shown in clinical trials to reduce HIV viral loads to undetectable levels in about 70% of previously untreated HIV-positive adults with advanced HIV disease. Glaxo hopes to have the drug approved for marketing in the United States by the second half of 2003. The company also plans to file for regulatory approval in Europe and hopes to begin selling the drug there by early 2004.