FDA Ad Committee - Avandia
GlaxoSmithKline PLC
31 July 2007
FDA Advisory Panel Votes 22 to 1 For Avandia(R) to Remain Available to Patients
in the US
30 July 2007 - Philadelphia, PA GlaxoSmithKline (NYSE: GSK) today welcomed the
nearly unanimous recommendation of an U.S. Food and Drug Administration's (FDA)
advisory committee to support Avandia's (rosiglitazone maleate) continued
availability to patients in the US. The company said it will continue to
provide information to the FDA to assist in the Agency's final decision-making.
On July 30th, the FDA Endocrinologic and Metabolic Drugs Advisory Committee and
the Drug Safety and Risk Management Advisory Committee voted that the data
suggests some ischemic risk with Avandia, a treatment for type 2 diabetes. The
committee declined to comment on comparative risk of Avandia to other oral
anti-diabetic medicines. The committee also voted to keep the medicine
available to patients in the US. The FDA will review the panel's recommendation
before making a decision.
"We welcome this decision as positive for patients. This was the first
opportunity for these scientific experts to review the full data behind Avandia.
The committee recognized the debilitating nature of this disease and the
importance of multiple treatment options," said Dr. Ronald Krall, Chief Medical
Officer, GlaxoSmithKline. "Diabetes is a progressive disease that exacts a
terrible toll on its victims, and it is important that Avandia remain a
treatment option for patients."
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. For company
information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.
S M Bicknell
Company Secretary
30th July 2007
Important Safety Information for Avandia(R) (rosiglitazone maleate)
Avandia, along with diet and exercise, helps improve blood sugar control. It may
be taken alone or with other diabetes medicines. For some people taking Avandia,
possible side effects include heart failure or other heart problems. Further
information regarding potential heart-related risks is currently under review by
the FDA. Talk to your doctor as FDA has made information on potential
heart-related risks available to physicians on its website at www.fda.gov. Tell
your doctor if you have heart problems or heart failure. Avandia can cause your
body to keep extra fluid, which leads to swelling and weight gain. Extra body
fluid can make some heart problems worse or lead to heart failure. If you have
swelling or fluid retention, shortness of breath or trouble breathing, an
unusually rapid increase in weight, or unusual tiredness while taking Avandia,
call your doctor right away. You should not take Avandia if you have liver
problems. Blood tests should be used to check for liver problems before starting
and while taking Avandia. Tell your doctor if you have liver disease, or if you
experience unexplained tiredness, stomach problems, dark urine or yellowing of
skin while taking Avandia. Tell your doctor about all of the medicines you are
taking. If you are taking Avandia with another diabetes medicine that lowers
blood sugar, you may be at increased risk for low blood sugar. Ask your doctor
whether you need to lower the dose of your other diabetes medicine. Avandia may
increase your risk of pregnancy. Talk to your doctor before taking Avandia if
you could become pregnant or if you are pregnant. If you are nursing, you should
not take Avandia. Talk to your doctor for advice on how to keep your bones
healthy. More fractures, usually in the upper arm, hand, or foot, have been seen
in women taking Avandia. Your doctor should check your eyes regularly. Very
rarely, some people have experienced vision changes due to swelling in the back
of the eye while taking Avandia.
US Media inquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Alice Hunt (215) 751 7709
UK Media inquiries: Phil Thomson (020) 8047 5502
Joss Mathieson (020) 8047 5502
Claire Brough (020) 8047 5502
US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
European Analyst/Investor inquiries: David Mawdsley (020) 8047 5564
Sally Ferguson (020) 8047 5543
This information is provided by RNS
The company news service from the London Stock Exchange
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