|
 July
25, 2002 - GlaxoSmithKline plc (GSK) today announces that
it has received approval from the Swedish regulatory authority
(MPA) for dutasteride, a new treatment for benign prostatic
hyperplasia (BPH).
The
MPA have approved an indication for its use in the treatment
of moderate to severe symptoms of BPH and for the prevention
of acute urinary retention (AUR) and surgery in patients with
BPH. They have agreed to act as the Reference Member State
for the Mutual Recognition procedure within Europe and GSK
plan to market the drug in all major European markets once
approvals are finalized.
Commenting
on the approval, Dr Ray Dawson, Senior Director of Urology,
European Clinical Development group at GSK said: "This
is good news as it provides both patients and prescribers
with a new treatment alternative. Clinical trials for dutasteride,
involving over 4,300 patients suffering from BPH, have demonstrated
that it provides long lasting symptom relief and positively
impacts on BPH progression. For instance, reductions over
placebo in prostate volume were seen as early as one month
and continued through the duration of the studies, which resulted
in significantly reduced incidence of acute urinary retention
and BPH related surgery. Both of these are key complications
of BPH progression."
Dutasteride
is the first 5-alpha reductase inhibitor (5ARI) that inhibits
both the type 1 and 2 isoenzymes of 5AR. These enzymes are
responsible for converting testosterone to dihydrotestosterone
(DHT) in the prostate and other tissues, and DHT has been
proven to play a key role in the development and progression
of BPH.
Overall,
in clinical trials, dutasteride was well tolerated and the
most commonly reported adverse events as reported in the approved
Summary of Product Characteristics were: Impotence (6%), altered
/ decreased libido (3.7%), ejaculation disorder (1.8%), gynaecomastia
(1.3%).
As
reported by Hairlosshelp.com in January, Glaxo confirms it
has delayed the release of Dutasteride until its supplemental
NDA (sNDA) filing containing its 2-year treatment data is
approved by the FDA. Glaxo filed the sNDA in December 2001
and will launch Dutasteride in the US upon approval of the
sNDA which is anticipated to be sometime in October 2002.
Hairlosshelp.com
has received unconfirmed reports that once the drug is on
the market, Glaxo will resume its Phase 3 hair loss studies.
|
