FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for the...

FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for
the Treatment of Symptomatic Enlarged Prostate

PHILADELPHIA, June 19 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) today announced that the U.S. Food and Drug Administration (FDA) has
approved AVODART (dutasteride) in combination with tamsulosin for the
treatment of symptomatic enlarged prostate, a disease that affects half of all
men over 50 years old. The new indication reflects emerging research showing
the combination of the two medicines treats the symptoms of enlarged prostate
more effectively than either medicine alone.
"The combination of AVODART and tamsulosin at diagnosis allows doctors to
simultaneously treat the patient's prostate on two fronts by reducing prostate
size and rapidly improving symptoms," said Steven A. Kaplan, M.D., from Weill
Cornell Medical College of Cornell University in New York City.
Common symptoms of enlarged prostate include nocturia, frequent and urgent
urination, incomplete emptying, starting and stopping, and weak stream. If
left untreated, enlarged prostate can lead to hospitalization for the
inability to urinate or prostate surgery.
AVODART already had been approved by the FDA for the treatment of enlarged
prostate to improve urinary symptoms, reduce the risk of acute urinary
retention (AUR), and reduce the risk of prostate-related surgery. Tamsulosin,
an alpha-blocker, already had been indicated for the treatment of the signs
and symptoms of enlarged prostate.
The FDA approval was based on two-year results of the CombAT (Combination
of Avodart and Tamsulosin) study, one of the largest clinical trials to date
of men with enlarged prostate. The CombAT study is the first long-term
assessment of the combination of AVODART and an alpha-blocker. Study results
were first presented in September 2007 at the 29th annual meeting of the
Societe Internationale d'Urologie in Paris. The study was published in the
February issue of the Journal of Urology.
The CombAT study results showed that combination therapy with AVODART and
tamsulosin was superior to both monotherapies at Month 12 and continued to
Month 24. The primary endpoint was the change in International Prostate
Symptom Score (IPSS) from baseline at Month 24 for combination therapy
compared to each medication alone. The most common adverse reactions reported
in subjects receiving combination therapy were impotence, decreased libido,
breast disorders (including breast enlargement and tenderness), ejaculation
disorders, and dizziness.
Data from the remaining 2 years of the CombAT study will provide further
information on the pattern of symptoms and long-term outcomes associated with
combination therapy vs. AVODART and tamsulosin monotherapies.
About CombAT
CombAT is a multicenter, randomized, double-blind and parallel-group
study. Men [aged greater than or equal to 50 years with a prostate volume (PV)
greater than or equal to 30 cc, serum prostate-specific antigen (PSA) level
1.5-10 ng/mL, Qmax >5 and less than or equal to 15 mL/sec with a minimum
voided volume greater than or equal to 125 mL and International Prostate
Symptom Score (IPSS) greater than or equal to 12] with moderate-to-severe
enlarged prostate symptoms received placebo for four weeks and were then
randomized to receive AVODART 0.5 mg/day and tamsulosin 0.4 mg/day (n=1610),
AVODART 0.5 mg/day (n=1623), or tamsulosin 0.4 mg/day (n=1611).
ABOUT AVODART
AVODART, the first and only dual 5ARI for the treatment of enlarged
prostate, inhibits both the type I and type II isoenzymes responsible for the
conversion of testosterone into dihydrotestosterone (DHT). DHT is the primary
male hormone responsible for the enlargement of the prostate. AVODART
suppresses DHT by 93 percent at 2 years. AVODART is indicated for the
treatment of symptomatic enlarged prostate in men with an enlarged prostate to
improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce
the risk of prostate-related surgery. AVODART is now indicated in combination
with the alpha blocker tamsulosin for the treatment of symptomatic enlarged
prostate. While some men have fewer problems and symptoms after three months
of treatment with AVODART, a treatment period of at least six months is
usually necessary to see if AVODART will improve symptoms.
Only a healthcare provider can tell if symptoms are from an enlarged
prostate and not a more serious condition such as prostate cancer. Men should
see their doctors for regular exams. Children and women who are or may become
pregnant should not take AVODART. Women who are or may become pregnant should
not handle AVODART. Men treated with AVODART should not donate blood until at
least six months after their final dose.
Caution should be used in patients with liver disease. Possible side
effects include sexual side effects and breast tenderness and/or swelling.
These side effects occur infrequently. For full prescribing information, see
www.avodart.com.
About Enlarged Prostate
Enlarged prostate is a prevalent and progressive disease that affects 50
percent of men over 50 years of age and over 90 percent of men older than age
80.1 An enlarged prostate causes changes in urinary habits because of its
location around the urethra. Over time, the prostate can continue to grow and
urinary symptoms may worsen as the bladder loses the ability to empty itself.
Left untreated, in severe cases, an enlarged prostate can lead to serious
long-term problems including acute urinary retention (AUR) and the need for
prostate-related surgery, and in rare cases even kidney or bladder damage.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. Company information line: 1-888-825-5249. Website address: www.gsk.com

* The International Prostate Symptom Score (IPSS) is a symptom index
for enlarged prostate that was developed and validated by a
multidisciplinary measurement committee of the American Urological
Association (AUA). The symptom index includes questions covering
frequency, nocturia, weak urinary stream, hesitancy, intermittence,
incomplete emptying and urgency.

Inquiries
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Tom Curry (215) 751 5419

SOURCE GlaxoSmithKline

US Media Inquiries: Rob Perry, +1-919-483-2839; or US Analyst, Investor
Inquiries: Frank Murdolo, +1-215-751 7002, or Tom Curry, +1-215-751-5419