FDA OKAYS BURROUGHS WELLCOME AZT AS AIDS TREATMENT
The Food and Drug Administration has
approved Burroughs Wellcome Co's AZT as a treatment to help
certain AIDS patients, including those with advanced-AIDS
related complex.
    The drug is the first approved treatment for AIDS in the
U.S. AZT or azidothymidine will be marketed as Retrovir by the
company, the U.S. arm of Britain's <Wellcome PLC>.
    Because of its limited supply, the FDA said the drug will
be restricted initially to those patients with AIDS or
AIDS-related complex with severely depressed immunity or a
history of Pnumocystis carinii, pneumonia.
    "Today's approval marks an important step but by no means a
final victory against our ongoing war against AIDS," said Dr
Robert E. Windom, assistant secretary for health at the Public
Health Service.
    He noted that available clinical data were sufficient for
approving the use of Retrovir only for certain indications and
not for all AIDS associated conditions.
    Nevertheless, Windom said today's action means that
significant medical relief will be available to thousands of
those afflicted with the disease.
    "Retrovir is not a cure but it has demonstrated ability to
improve the short-term survival of AIDS patients with recently
diagnosed PCP (Pneumomystis carinii pneumonia) and certain
patients with advanced ARC (AIDS-related complex)," said
Windom.
    Advanced AIDS related complex is a condition that
frequently precedes and develops within a short time into
full-scale acquired immune deficiency syndrome.
    As of March 16, there were 32,825 AIDS cases reported
nationwide, with more than 16,000 deaths.
    The Public Health Agency said advanced ARC patients have
symptoms that include weight loss, persistent fever and
diarrhea, and less severe infections such as oral thrush and
herpes infections.
    The federal agency said that AIDS patients who are expected
to qualify for retrovir treatment are those who have serious
opportunistic infections associated with AIDS and those with
advanced AIDS related complex.
    It is estimated that about two to three times as many
Americans may suffer from advanced ARC as from AIDS.
    Burroughs Wellcome, of Research Triangle Park, N.C., has
scheduled a press conference for Monday in New York where it
will discuss what patients will quality for treatment. The
company has said that a year's treatment with the drug would
cost 8,000 dlrs to 10,000 dlrs.
    Burroughs has also said that it has adequate supplies of
the drug for the most seriously ill patients, and will have
supplies for a minimum of 30,000 patients and probably more by
the end of the year.
    Retrovir's approval was expected as a panel of expert
medical advisers to the FDA recommended in January that the
drug be licensed for sale even though there were gaps in
understanding the drug's effectiveness.
    The panel said the drug could prolong the lives of certain
AIDS patients but it also caused severe side effects such as
anemia and other blood problems.
    Due to the extraordinary situation surrounding AIDS, a
fatal disease reaching what some health officials say is
epidemic proportions, Windom said the FDA has moved in near
record time--four months--to approve the drug.
    AZT, derived from herring sperm, was created in the 1960s
by Jerome P. Horwitz of the Michigan Cancer Foundation as an
anticancer agent.
    Meanwhile in London, dealers said Wellcome shares rose to
497p in response, up from last night's close of 457p.
    But pharmaceutical analyst Mark Clark of Barclays de Zoete
Wedd said the new drug's share of the market may not be as a
high as expected since it had very severe side effects.
    "It is not a cure and the side effects are so bad it is
unlikely that someone could support a full year's treatment," he
said. "There are also a whole host of other drugs likely to come
onto the market quite soon."
    Last week the drug was approved for marketing in the U.K.
 Reuter
