New Drug Application for Prostate Cancer Treatment
AstraZeneca PLC
28 February 2000
ASTRAZENECA FILES SUPPLEMENTAL NEW DRUG APPLICATION WITH
FDA FOR CASODEX 150MG MONOTHERAPY FOR THE TREATMENT OF
PROSTATE CANCER
AstraZeneca today announced that a supplemental new drug
application (sNDA) has been filed with the US Food and
Drug Administration (FDA) for Casodex 150mg monotherapy
for the treatment of locally advanced, non-metastatic
prostate cancer.
Data from two clinical studies submitted for FDA review
show that Casodex 150mg is the first anti-androgen as
monotherapy to offer men a more acceptable alternative to
the currently available options of surgical or medical
castration, both of which have significant quality of
life issues. Quality of life data indicate there are
significant improvements in maintenance of sexual
interest and in physical capacity in comparison with
those patients who had castration, making Casodex 150mg
monotherapy a suitable treatment for men with earlier
stage disease.
Casodex as a 50mg once-daily tablet was first introduced
in 1995 as a treatment for advanced prostate cancer in
combination with an LHRH analogue or surgical castration.
Casodex 150mg monotherapy has already been approved by
the regulatory authorities in several countries including
the UK and Sweden and further approvals are expected in
2000.
Casodex is the world's leading brand of anti-androgen. It
is now available in over 70 markets worldwide with sales in
1999 of USD 340 million.
AstraZeneca is a major international healthcare business
engaged in the research, development, manufacture and
marketing of ethical (prescription) pharmaceuticals and
the supply of healthcare services. It is one of the top
five pharmaceutical companies in the world with
healthcare sales of over USD 15 billion and leading
positions in sales of gastrointestinal, oncology,
anaesthesia including pain management, cardiovascular,
central nervous system (CNS) and respiratory products.
28 February 2000
Analyst/investor enquiries:
Elizabeth Sutton (020) 7304 5101
Michael Olsson (020) 7304 5087
Ed Seage (Wilmington) (302) 886 4065
Jorgen Winroth (Wayne) (609) 896 4148
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