News
06/26/1989

<TITLE>R-erythropoietin for Anemia in AIDS patients</TITLE>
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R-erythropoietin for Anemia in AIDS patients

P89-31                                        Food and Drug Administration
FOR IMMEDIATE RELEASE                         Brad Stone -- (301) 443-3285

    HHS Secretary Louis W. Sullivan, M.D., announced today that the Food and
Drug Administration is permitting expanded premarket distribution of an 
experimental protein product to treat the severe anemia that weakens nearly 
half the 20,000 patients currently taking zidovudine, commonly known as AZT,
for AIDS.  The drug will also be made available to the smaller number of
AIDS patients suffering from anemia related to the disease itself.
    "The early release of this product," Secretary Sullivan said, "shows
that HHS and its constituent FDA mean business when we say we want to speed 
the availability of AIDS-related drugs."
    In the past, the severe anemia associated with AZT and AIDS has required
repeated blood transfusions.  In some cases, AZT has had to be discontinued.
    The protein product, r-erythropoietin, is a form of a protein formed in 
the kidneys, erythropoietin, which stimulates the body's production of red
blood cells.  Scientists are able to make quantities of the protein for 
treatment through gene-splicing techniques. 
    Another erythropoietin product was approved by FDA on June 1, as a
treatment for anemia associated with chronic kidney failure.  However,
today's action provides an experimental treatment regimen specifically
designed to treat this AIDS-related anemia.  Physicians participating in the
r-erythropoietin protocol will receive the product at no cost.
    FDA Commissioner Frank E. Young, M.D., Ph.D., said, "This new biotech 
product should improve the quality of life for those whose lives depend upon
zidovudine.  Its premarket release -- the fourth for AIDS-related products
-- reaffirms HHS' and FDA's commitment to providing people with 
life-threatening and serious diseases the earliest possible access to 
promising treatments."  FDA is a part of the Public Health Service within 
HHS.
    In controlled clinical studies involving more than 100 AIDS patients who
had experienced severe anemia from zidovudine, r-erythropoietin appeared to 
restimulate the production of red blood cells and reduce or eliminate the 
need for transfusions.
    The data from this study served as the basis for granting today's 
"treatment IND" status.  (IND stands for investigational new drug.)  This 
status allows patients suffering from serious or life-threatening conditions
to get pre-approval access to experimental drugs that have shown significant
promise.
    Under this treatment IND protocol, AZT patients and other AIDS patients 
who have experienced severe anemia will be eligible to receive
r-erythropoietin treatment.  The product will initially be in limited supply
but its availability will be expanded during the next several weeks.
    Ortho Pharmaceutical Corp. of Raritan, N.J., will sponsor the treatment 
IND protocol.  The company has also filed a product license application for 
r-erythropoietin which FDA is currently reviewing.
    Physicians interested in the details of this treatment IND protocol can 
contact an Ortho hotline at (800) 243-7739. 
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