As many as 6 million people in the U.S.
suffer from gout, a type of arthritis in
which deposits of uric acid build up
around joints, causing pain, swelling
Acute gout is a painful condition that
typically affects one joint.
Chronic gout is repeated episodes of
pain and inflammation, which may
involve more than one joint.
KRYSTEXXA FROM SAVIENT
PHARMA IS HELPFUL FOR SEVERE
Savient Pharmaceuticals Inc.’s
treatment for chronic, severe gout
helped patients who didn’t respond to
other medications, about 3 percent of
of the market. These were targeted for
the trials, conducted in 2006 and 2007.
Savient’s Krystexxa, approved by the
U.S. regulators in 2010, lowered uric
acid levels below targeted amounts in
42 percent of 84 patients given the
drug biweekly, compared with 35
percent who took the medicine
monthly, and zero response in the
placebo group, according to the
research published in the Journal of
the American Medical Association.
NOVARTIS HAS PROMISING DRUG
In June 2011 the U.S. FDA regulatory
panel questioned the safety of the
gout treatment Ilaris (canakinumab or
ACZ885), asking for more testing.
The adverse regulatory stance could
delay or block the launch of Ilaris in the
U.S. if the FDA backs the panel.
One of Novartis's top blockbuster
hopefuls registered promising data in
two pivotal trials for gout, offering
supportive data for a string of
regulatory filings in Europe and the U.
ACZ885--an antibody also known as
Ilaris which blocks the interleukin-1
beta protein--provided significantly
improved pain relief and a sharp
reduction in the risk of fresh attacks of
gout compared to an injectable steroid.
Investigators recruited more than 450
patients for the studies who didn't fit
the profile for standard therapies.
Analysts give the treatment a solid
shot at achieving blockbuster status
with more than a billion dollars in
annual revenue--provided the pharma
company can continue to broaden the
use of the drug beyond the one
percent to four percent of the
population which suffers from gouty
arthritis with new indications for use.
Professor Alexander So, one of the
studies' investigators says:
"Scientists only recently learned that
the root cause of the pain in gouty
arthritis is interleukin-1 beta. Through
specifically targeting interleukin-1 beta,
these studies show ACZ885 can
effectively treat painful attacks while
extending the time to new attacks."
REGENERON PHARMA HAS
PROMISING THERAPY IN PHASE 3
Regeneron Pharmaceuticals Inc.
(REGN) said its gout therapy Arcalyst
met all its primary and secondary goals
in Phase 3 studies, a milestone on its
path to regulatory approval.
Those taking an injection of 80 or 160
milligrams a week of Arcalyst over four
months had a decrease of 72 percent
in gout flares compared with placebo.
The data, from the third and final stage
of testing generally required for
approval, will support an application
with U.S. regulators by mid-2011, the
About 750,000 gout patients start
taking uric acid-lowering therapy such
as allopurinol each year.During the
first few months of therapy, the
breakup of uric acid crystals can cause
flares of joint pain, which Arcalyst aims
to prevent. If successful, the medicine
may generate up to $500 million in
Arcalyst “may have significant potential
as a co-treatment in allopurinol
initiation for chronic gout.
RDEA594 TESTED FOR
NORMALIZING URIC ACID IN GOUT
The lead product from Ardea
Biosciences, Inc., of San Diego,
California, is Lesinurad (RDEA594),
for the chronic management of
hyperuricemia in patients with gout. It
is a once-daily, oral inhibitor of the
The company has completed Phase 2b
clinical studies of lesinurad and
continue preparations for Phase 3