GSK Statement on FDA's Proposed Label Revisions for Some Asthma Medicines
RESEARCH TRIANGLE PARK, N.C., Feb. 18 /PRNewswire-FirstCall/ --
GlaxoSmithKline (NYSE:GSK) is reviewing label changes proposed
today by the US Food and Drug Administration (FDA) for asthma
medications containing long-acting beta-agonists (LABAs), such as
GSK's Advair (salmeterol / fluticasone propionate). GSK and makers
of the other affected medicines containing LABAs have 30 days to
agree with the proposed changes or state why they are not
warranted.
"We will work with FDA to ensure that the final label for these
products protects the interest of patients who suffer with this
chronic and serious disease," said Dr. Katharine Knobil, vice
president for respiratory clinical research at GSK. "It is
important that doctors have flexibility to make the proper clinical
decisions to help patients gain and maintain optimal control of
their asthma."
The FDA's action relates to asthma and does not pertain to the
chronic obstructive pulmonary disease (COPD) indication for
Advair.
The available data were reviewed by three FDA advisory
committees that met jointly in December 2008 and voted unanimously
that Advair has a positive benefit-risk profile as currently
labeled for adult patients. No new data have entered into FDA's
decision-making.
There is no evidence from more than 10 years of data from
clinical trials, observational studies and worldwide clinical
experience exceeding 30 million patient-years of use that Advair is
associated with an increased risk of asthma-related death,
hospitalization or other serious respiratory-related outcomes in
any age group. There have been no asthma-related deaths in clinical
trials involving nearly 18,000 patients taking Advair.
Combination asthma medicines, such as Advair, that contain a
LABA and an inhaled corticosteroid (ICS) play an important role in
the treatment of asthma because they treat both main causes of
asthma symptoms -- inflammation and bronchoconstriction.
National Institutes of Health and international asthma treatment
guidelines currently recommend use of combination medicines (ICS
plus LABA) for patients whose asthma is not controlled on low-dose
ICS and in patients whose disease is severe enough to warrant
beginning treatment with a combination medicine.
Data show that Advair has a favorable safety profile and is
effective in treating asthma by improving lung function, reducing
and helping to prevent symptoms, and reducing the need for rescue
medicine compared to ICS. There was no evidence in clinical trials
for Advair of increased risk for asthma-related death,
asthma-related hospitalization, asthma-related intubation or all
cause death compared to other treatments options.
Observational studies showed a significant decrease in
asthma-related hospitalization in adults receiving Advair versus
ICS alone, and a significant decrease in asthma-related
hospitalizations and emergency department visits in children
receiving Advair versus ICS alone and versus ICS plus
montelukast.
As with all medications, the decision to stop or change any
therapy should be discussed with a physician.
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 further information please visit
www.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the
company' s Annual Report on Form 20-F for 2008.
Source: GlaxoSmithKline
CONTACT: UK Media enquiries, 020-8047-5502, Philip Thomson,
Claire
Brough, Stephen Rea, Alexandra Harrison, Jo Revill; US Media
enquiries,
+1-919-483-2839, Nancy Pekarek, Mary Anne Rhyne, Kevin Colgan,
Sarah Alspach;
European Analyst-Investor enquiries, David Mawdsley, 020-8047-5564,
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Ferguson, 020-8047-5543, Gary Davies, 020-8047-5503; US
Analyst-Investor
enquiries, Tom Curry, +1-215-751-5419, Jen Hill Baxter,
+1-215-751-7002, all
of GlaxoSmithKline
Web Site: http://www.gsk.com/
Posted: February 2010
