To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Twice-Daily Dosing Of Viracept For HIV URL: http://www.pslgroup.com/dg/14CA96.htm Doctor's Guide November 30, 1999
LA JOLLA, CA -- November 30, 1999 -- Agouron Pharmaceuticals, Inc. today announced that the Food and Drug Administration (FDA) has approved twice daily dosing (BID) of Viracept(R) (nelfinavir mesylate) for the treatment of HIV infection. Approval supports 1250mg BID dosing of Viracept based on data that showed comparable anti-HIV effects and safety to the previously approved 750mg three times daily dosing (TID). "We are gratified that the FDA has approved twice daily dosing for Viracept," said Peter Johnson, Agouron's president and chief executive officer. "This simpler and more convenient dosing schedule for Viracept, that preserves its safety, tolerability and anti-HIV potency, will further enhance the utility of the most extensively prescribed HIV protease inhibitor in the United States." The clearance was based principally on interim results from a pivotal phase III trial involving more than 500 patients that showed similar decreases in plasma HIV RNA and increases in CD4+ T cell counts between 1250mg BID and 750mg TID dosing of Viracept and a similar safety profile, when used in combination with standard doses of Zerit(R) (d4T or stavudine) and Epivir(R) (3TC or lamivudine).