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AIDS drug finds a booster in FDA panel.


A federal advisory panel recommended on April 21 that the U.S. Food and Drug Administration give a new AIDS drug conditional approval. The drug, dideoxycytidine dideoxycytidine /di·de·oxy·cy·ti·dine/ (-si´ti-den) a dideoxynucleoside in which the base is cytosine; it is an antiretroviral agent that acts by inhibiting reverse transcriptase and is used in treating acquired immunodeficiency syndrome.  (DDC See VESA DDC. ), would be used in combination with zidovudine (AZT AZT or zidovudine (zīdō`vydēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called ), the first antirival AIDS drug approved by the agency.

The panel's action is part of an effort to speed up federal approval of lifesaving drug, especially drugs aimed at combating the deadly virus that causes AIDS.

DDC manufacturer Hoffman-LaRoche, Inc., of Nutley, N.J, presented the panel with preliminary clinical data showing that DDC administered with zidovudine helped boost the immune system people with AIDS The People With AIDS (PWA) Self-Empowerment Movement was a movement of those diagnosed with AIDS and grew out of San Francisco. The PWA Self-Empowerment Movement believes that those diagnosed as having AIDS should "take charge of their own life, illness, and care, and to minimize  or a severe precursor to AIDS. Those preliminary studies involved about 150 people monitored for up to one year, says Hoffman-LaRoche scientist Paul Oestreicher.

The FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 says it is considering the panel's recommendation. Under the accelerated approval plan, the agency can okay an experimental drug based on early data. If further studies negate the drug's promise, then the FDA can revoke approval.

The committee stopped short of recommending that FDA approve DDC as a sole treatment for AIDS, saying the company failed to prove that DDC is as effective as zidovudine.
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Copyright 1992, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:dideoxycytidine
Publication:Science News
Article Type:Brief Article
Date:May 2, 1992
Words:191
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