Subject: FDA Application Is Filed For ddC
Date: Published: 11/1/91 (30 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology Brief -- Hoffmann-La Roche Inc.:
    FDA Application Is Filed
    For DDC, an AIDS Drug

    Hoffmann-La Roche Inc. said it completed the filing of a
 new drug application with the Food and Drug Administration
 covering its AIDS drug DDC. 
    The 550-volume submission comprises 165,000 pages of data
 on the testing, safety and efficacy of the drug, which has
 been given the trade name HIVID. Clinical trials of the drug
 began in 1987, and currently 8,000 people are receiving the
 drug in Roche's clinical and expanded access programs for
 people with AIDS.  
    The company, based in Nutley, N. J., said it is asking FDA
 to approve marketing of DDC for people who have failed to
 improve or developed intolerance to the Wellcome PLC drug
 AZT.  The application also seeks approval of DDC as a
 first-line therapy in combination with AZT, following
 promising studies unveiled at the International AIDS
 Conference in Florence in June.
    Hoffmann-La Roche is the U. S. unit of Roche Holding Ltd.
 of Basel, Switzerland.

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