Subject: Bristol-Myers's Videx Is Cleared For Wider Use Date: Published: 9/29/92 (52 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Technology & Health: Bristol-Myers's Videx Is Cleared For Wider Use ---- By Elyse Tanouye Staff Reporter of The Wall Street Journal NEW YORK -- Bristol-Myers Squibb Co. said the Food and Drug Administration has approved expanded use of Videx, the company's anti-viral drug to treat HIV infection. Videx, or didanosine (commonly called DDI), was first approved last October only for patients who couldn't tolerate AZT, made by Burroughs Wellcome Co., a unit of Wellcome PLC in London. The new FDA approval allows anyone to switch to Videx after trying AZT. The two drugs are the only ones approved by the FDA to slow the progression of HIV, or human immunodeficiency virus, which leads to AIDS. The latest approval was based on a study published last month in the New England Journal of Medicine that suggested switching to DDI from AZT slows the onset of full-blown AIDS, or acquired immune deficiency syndrome. The study suggested Videx is superior to AZT in reducing secondary infections in patients with AIDS-related complex, or ARC, a precursor condition. Moreover, patients on AZT had higher rates of severe anemia and leukopenia, the depletion of certain red and white blood cells, than those on DDI, according to the National Institute of Allergy and Infectious Diseases, which supported the study. In patients with full-blown AIDS, DDI appeared equal to AZT in effectiveness. The study, led by James Kahn of San Francisco General Hospital, found no difference in death rates between the two drugs. Samuel Isaly, a pharmaceutical analyst and partner in Mehta & Isaly, a research firm, said the approval doesn't change Videx's status as a second-choice drug. "What would really represent an advance is if it were designated as first-choice therapy," he said, adding that such an approval isn't expected. Mr. Isaly said he estimates Videx sales will be $100 million in 1993, while AZT will top $400 million. A Burroughs Wellcome spokeswoman declined to comment on the effect of DDI's expanded use on AZT sales. "AZT is a well established drug indicated for a broad spectrum of HIV disease and we expect it will continue to be used in that fashion." She also pointed out that the trend in HIV treatment is toward combination therapy, using two or more drugs. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]