NEWS

03/14/1996



<TITLE> FDA GRANTS ACCELERATED APPROVAL TO THIRD PROTEASE

INHIBITOR TO TREAT HIV </TITLE>

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P96-5                              Food and Drug Administration

FOR IMMEDIATE RELEASE              Ivy F. Kupec (301) 443-3285

March 14, 1996                                        



FDA GRANTS ACCELERATED APPROVAL TO 

THIRD PROTEASE INHIBITOR TO TREAT HIV



     The Food and Drug Administration announced today it has

granted accelerated approval to the third in a new class of AIDS

drugs called protease inhibitors.  Indinavir, the new drug,

received accelerated approval late yesterday for use alone or in

combination with nucleoside analogue medications, such as AZT, in

people with HIV or AIDS.  FDA approved the drug just 42 days

after receiving its application for its marketing.

     "The Clinton Administration is committed to the fight

against AIDS, including the President's ultimate goal of a cure

for this disease," said HHS Secretary Donna E. Shalala. "Rapid

FDA action on important new drugs is one important part in

reaching the long-term goal."

     "The pharmaceutical companies that have led the development

of protease inhibitors deserve a lot of credit," said

Commissioner of Food and Drugs David A. Kessler, M.D.  "It's been

an historic period in the fight against AIDS.  This accelerated

approval -- a new record for the agency -- is further

confirmation of our commitment in the fight."

     FDA based its approval for indinavir on data showing that  

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the drug improves laboratory markers, such as CD4 counts, an

indication of immune system strength, and viral load, a measureof

the amount of virus that can be detected in the bloodstream. 

     In clinical studies, indinavir was studied alone and in

combination with nucleoside analogues in HIV-infected people in

various stages of disease.  Each of these trials monitored

changes in participants' CD4 cell counts and viral load. 

     These results were shown primarily in two controlled

clinical trials involving a total of 490 patients.  The trials

studied one group receiving indinavir alone, another group

receiving the drug in combination with AZT, and a third group

treated with just AZT.  

     FDA also reviewed data from a small study that evaluated the

progress of 96 patients using indinavir in combination with two

nucleoside analogues, AZT and 3TC.

     Clinical data indicated that patients receiving indinavir

alone or in combination with nucleoside analogues experienced a

marked increase in their CD4 levels and had a marked decrease in

their viral load.

     FDA grants accelerated approval, a regulatory mechanism that

allows for early marketing approval for a product based on

laboratory markers, with the understanding that the drug sponsor

must eventually demonstrate that the product provides true

clinical benefit with endpoints such as extended life span or

slower disease progression.  Otherwise, the agency may withdraw 

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the granted accelerated approval.  Two trials are ongoing to

evaluate the clinical benefits of indinavir.

     Among the major adverse events reported with indinavir

therapy were infrequent kidney stones and frequent increases in

bile production.

     Indinavir is manufactured by Merck & Co. Inc. under the

trade name CrixivanTM.        ####

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