News
08/06/1990

<TITLE>Surfactant for Preemies </TITLE>
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Surfactant for Preemies 

P90-41                                            Food and Drug Administration
FOR IMMEDIATE RELEASE                             Eva Kemper -- (301) 443-3285

    The Food and Drug Administration today approved a drug for the inside of
immature lungs that may save thousands of premature infants born with an
often fatal breathing difficulty called Respiratory Distress Syndrome.
    The drug comes as a powder to be mixed with sterile water and then given
through a tube into the windpipe.  It goes to the lungs where it substitutes
for a naturally occurring surfactant -- a foamy substance that coats the
inside of the lungs and keeps them from collapsing when the infant exhales. 
The premature infants must be on a mechanical ventilator to receive the drug. 
    In 1963, a baby boy born to President and Mrs. John F. Kennedy died of
the condition.
    Although in the past two decades great strides have been made against 
the syndrome, it remains a leading cause of death and disability among
premature infants.  Among about 250,000 infants born prematurely each year
in the United States, up to 50,000 have the condition, which kills about
5,000.
    The surfactant can be administered in up to 3 doses starting immediately
after birth to help prevent death in high-risk infants under 1,350 grams
(under 3 pounds) or in two doses, 12 hours apart, to treat infants who have 
                                   



                                            P90-41, Exosurf, Page 2 
developed the disease.
    Burroughs Wellcome Co. of Research Triangle Park, N.C., will distribute 
surfactant under the trade name Exosurf Neonatal.  Exosurf was invented by
Dr. John Clements of the University of California at San Francisco and
licensed to Wellcome.  The product was also designated an "orphan drug" by
FDA, under a program which provides incentives for development and
production of drugs and other medical products to treat conditions affecting
small patient populations.
    Because of its importance, the drug was made widely available, while
still experimental, in July of 1989 under FDA's Treatment IND program.  The 
new drug application to market the drug was received in February and
approved by the FDA in a near-record five months. 

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