NEWS 02/02/1996
NOTE TO CORRESPONDENTS Ivy Fleischer Kupec
February 2, 1996 (301) 443-3285
FDA ADVISORY COMMITTEE TO DISCUSS VARIOUS AIDS TREATMENTS
The Food and Drug Administration will convene a Feb. 28-
March 1 meeting of its Antiviral Drugs Advisory Committee and
other outside experts to review marketing applications for two
protease inhibitor drugs to treat HIV infection and to discuss
recent studies of the clinical effectiveness of nucleoside
analogue drugs used in combination to delay the complications of
HIV infection. Additionally, on March 1st, FDA will convene its
Endocrinologic and Metabolic Drugs Advisory Committee to review a
marketing application to treat AIDS-related wasting.
On Wednesday, Feb. 28, the committee will discuss recent
studies of nucleoside analogues, AZT, ddI and ddC, used to treat
HIV infection, including the AIDS Clinical Trial Group (ACTG)
Study 175, the Delta study, CPCRA 007 and other relevant studies.
This session will be held at Holiday Inn-Gaithersburg Grand
Ballroom, Two Montgomery Village Ave.
On Thursday, Feb. 29, the committee will review data on the
safety and effectiveness of ritonavir, the protease inhibitor
which Abbott Laboratories manufactures in both liquid and
capsules to treat HIV infection. This session also will be held
at Holiday Inn-Gaithersburg.
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Page 2, NTC, Protease inhibitor
On Friday, March 1, the committee will deliberate on the
safety and activity data for indinavir, Merck & Co.'s protease
inhibitor. This session will be held at the Holiday Inn-
Gaithersburg.
Also on Friday, March 1, the FDA's Endocrinologic and
Metabolic Drugs Advisory Committee and outside experts will meet
to discuss Serono's growth hormone, somatropin, for AIDS-related
wasting at the Holiday Inn-Silver Spring Plaza Ballroom, 8777
Georgia Ave.
All sessions will allow for public comments around the
midday and are planned to run 8:30 a.m.- 5 p.m., with one
exception. The session on somatropin begins at 8 a.m.
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