FDA APPROVES FIRST PROTEASE INHIBITOR DRUG FOR TREATMENT OF HIV

NEWS 12/07/1995 FDA APPROVES FIRST PROTEASE INHIBITOR DRUG FOR TREATMENT OF HIV



P95-10                             Food and Drug Administration

FOR IMMEDIATE RELEASE              Arthur Whitmore (301) 443-3285

Dec. 7, 1995                       





FDA APPROVES FIRST PROTEASE INHIBITOR DRUG FOR TREATMENT OF HIV   

     The Food and Drug Administration today approved the first

protease inhibitor, a new class of therapy for the treatment of

advanced HIV infection.  Saquinavir, the new drug, received

approval for use in combination with older nucleoside analogue

medications only three months after the agency received the

application for its marketing.

     "This is some of the most hopeful news in years for people

living with AIDS," said HHS Secretary Donna E. Shalala.  "Today's

approval introduces a new class of drugs for treating AIDS.  This

drug was approved in just 97 days -- evidence that FDA is carrying

through on the Clinton Administration's priority to review new

drugs, especially the most promising new drugs, on the fastest

possible track consistent with safety."

     Commissioner of Food and Drugs David A. Kessler, M.D., pointed

out that five of the six AIDS therapies approved so far were

reviewed in six months or less.

     "The review of saquinavir is the fastest approval of any AIDS

drug so far, and demonstrates FDA's flexibility in situations when

saving time can mean saving lives," Kessler said.  "When it comes 

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to AIDS and other life-threatening diseases, we have learned to

take greater risks in exchange for greater potential health

benefits."

     Both protease inhibitors and nucleoside analogues chemically

inhibit replication of the human immunodeficiency virus, although 

at different points in the replication process.  Nucleoside

analogues include the already-approved anti-HIV drugs AZT, ddC,

ddI, d4T and 3TC.

     The agency based its approval of saquinavir on clinical trials

comparing three drug combinations in more than 900 HIV-infected

individuals:  saquinavir with AZT, saquinavir with ddC, and

saquinavir with both AZT and ddC.  The primary measure of drug

effect was changes in patients' CD4 cell counts, an indication of

immune system strength.  (Values greater than 800 per milliliter of

blood are normal in healthy individuals.)  

     Over 16 weeks of treatment, CD4 cell counts increased an

average of 30 to 40 cells above entry levels in patients on

saquinavir in combination with ddC or AZT or AZT plus ddC.  Effects

were attributable to combinations of saquinavir and a nucleoside

analogue to which a patient had not been previously exposed.

Saquinavir doses of less than 600 mg three times a day did not

produce increases in CD4 cell counts.  The duration of CD4 cell

increases is not fully determined, although in general it lasted 

for at least the 16 weeks of the trials. 

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                                       Page 3, P95-10, Saquinavir

     Few adverse events were associated with saquinavir, and for

most patients the drug was well tolerated. 

     FDA's approval of the saquinavir marketing application was

granted as an accelerated approval, a regulatory mechanism under

which the agency bases early approval for a product on laboratory 

markers such as CD4 cell counts, rather than on clinical endpoints

such as delay in death or reduction in opportunistic infections. 

     FDA may withdraw the approval of products granted accelerated

approval if post-marketing studies fail to verify clinical

benefits.  Trials designed to demonstrate clinical benefits of

saquinavir in combination with other nucleoside analogues are

ongoing. 

     Saquinavir is manufactured by Roche Laboratories under the

trade name Invirase.     

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