HHS NEWS

P97-11                         Food and Drug Administration
FOR IMMEDIATE RELEASE          Jason Brodsky:   (301) 827-3417
March 14, 1997                 
                               Consumer Hotline:(800) 532-4440

            FDA APPROVES FIRST PROTEASE INHIBITORS WITH
                LABELING FOR USE IN CHILDREN

     The Food and Drug Administration today approved two HIV
protease inhibitors -- some of the most powerful medicines against
the infection -- for use in treating children. 
      Nelfinavir received its initial approval today -- including
information on use in both adults and children -- approximately 3
months after its application was received.  The labeling for
nelfinavir includes a "pediatric use" statement, giving doctors
specific dosage recommendations for patients 2 to 13 years old. In
addition, ritonavir, a previously approved protease inhibitor, also
received "pediatric use" labeling today.
     "Today's actions not only add another powerful weapon to our
arsenal for treating HIV infection, but provide us with critical
information on using these cutting edge drugs to help HIV positive
children," said HHS Secretary Donna E. Shalala.
     "With each approval, we are providing more options in
designing individualized treatment programs for adults and
children," said Dr. Michael A. Friedman, FDA Lead Deputy
Commissioner. 
     The "pediatric use" section in the drug labeling provides
specific recommendations for the use of the drugs in children.  A
regulatory reform initiated in 1994 eased the process of including
label information that helps physicians in treating pediatric
patients -- particularly in serious or life-threatening situations. 
Now, such information can be provided when evidence suggests that
the course of the disease and the effects of the drug are
sufficiently similar in the pediatric and adult populations to
permit extrapolation from adult efficacy data to pediatric
patients.
     Nelfinavir received accelerated approval, a regulatory
mechanism under which FDA bases early marketing approval for a
product on laboratory markers such as plasma HIV RNA (a measure of
viral load) and CD4 cell counts until information about clinical
endpoints such as disease progression or mortality is available.
     FDA based its approval of nelfinavir on studies of up to 24
weeks in duration showing that the drug was active in combination
with other antiretroviral drugs for the treatment of HIV or if
administered alone.  However, because the antiviral activity of
nelfinavir is increased when used with other drugs approved for
treatment of HIV, combination therapy is recommended.
     The most frequent adverse event associated with the use of
nelfinavir is diarrhea, which can usually be controlled with 
nonprescription drugs.  Other adverse events reported during
clinical trials included nausea, vomiting, and asthenia.
     Nelfinavir should not be administered concurrently with
terfenadine, astemizole, cisapride, trizolam or midazolam, because
these drugs may inhibit its metabolism and create the potential for
serious and/or life-threatening cardiac arrhythmias or prolonged
sedation.  FDA has worked with the manufacturer to ensure that
these drug interactions with nelfinavir are clearly highlighted on
the package label and that patient education materials are made
available to health care professionals and patients.
     Agouron Pharmaceuticals is marketing nelfinavir under the
trade name Viracept.  Ritonavir is marketed under the trade name
Norvir by Abbott Laboratories.
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