18th Nov 2005 17:11
GlaxoSmithKline PLC18 November 2005 November 18, 2005 GSK STATEMENT ON FDA PROPOSED LABELING CHANGE FOR SEREVENT AND ADVAI RESEARCH TRIANGLE PARK, N.C. - GlaxoSmithKline disagrees with the FDA's proposedproduct labeling changes for Serevent and Advair, because they are inconsistentwith established NIH treatment guidelines and the standard of care for asthmatreatment, which could put many patients at risk of uncontrolled asthma. The proposed changes are a departure from recent outcomes of a July 2005 FDAadvisory committee meeting that reinforced the favorable benefit-to-risk profileof both medicines. The advisory committee supported the use of long-actingbeta-agonists (LABA) in combination with inhaled corticosteroids (ICS) andproposed no new restrictions. Since that time, there have been no new data onthe safety or efficacy about salmeterol used alone or in combination with ICS. "Patient safety is of paramount concern to GSK which is why we disagree with theFDA's proposed labeling changes," said Dr. Kathy Rickard, GSK Vice PresidentClinical Development and Medical Affairs, respiratory medicine in the U.S. "These proposed labeling changes would reserve the most effective asthmatreatment - the combination of inhaled corticosteroids and long-acting betaagonists - until after a patient has failed on other treatment options andtherefore may be at risk for severe outcomes, such as exacerbations andpotentially death." GSK believes sufficient safety information about these medicines is already inthe labels to help guide physicians about their appropriate use. However, wewill work with FDA to address the differences of opinion about how best tocommunicate the benefit risk profile of these medicines for optimal patientcare. The current labeling of Advair is consistent with asthma treatment guidelinesestablished by the NIH and supported by GSK. These guidelines position ICS andLABA as first-line therapy for moderate to severe persistent asthma, and aresupported by a significant body of evidence. Asthma is a chronic condition that affects 20 million Americans, causing about5,000 deaths each year. The risk of uncontrolled asthma is significant and couldcause life-threatening situations requiring emergency room visits,hospitalization and even causing death. African Americans and Hispanics arethree to five times more affected by asthma in the U.S. GSK has confidence in the proven safety profile of Advair and Serevent whenthese products are used appropriately and in line with national treatmentguidelines. There have been 81.9 million prescriptions filled to date in theU.S. for Advair alone. GlaxoSmithKline is committed to the appropriate use of its medicines andcommunicating safety information about its products. GSK has worked diligentlyto ensure physicians have the latest information about Serevent and Advair,which are among the most studied asthma medicines worldwide and have benefitedmillions of patients. About Serevent: Serevent Diskus is indicated for long-term twice-daily (morning and evening)administration in the maintenance treatment of asthma and in the prevention ofbronchospasm in patients 4 years of age and older with reversible obstructiveairway disease, including patients with symptoms of nocturnal asthma, whorequire regular treatment with inhaled, short-acting beta2-agonist. It is notindicated for patients whose asthma can be managed by occasional use of inhaled,short-acting beta2-agonists. About Advair: Advair Diskus is indicated for the long-term, twice-daily, maintenance treatmentof asthma in patients 4 years of age and older. Advair Diskus is NOT indicatedfor the relief of acute bronchospasm. S M BicknellCompany Secretary18 November 2005 GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better and live longer. Inquiries:US Media inquiries: Lisa Behrens (919) 483 2839 Patricia Johnson (919) 483 2839 Mary Anne Rhyne (919) 483 2319 UK Media inquiries: Philip Thomson (020) 8047 5502 David Mawdsley (020) 8047 5502 Chris Hunter-Ward (020) 8047 5502 US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 European Analyst/Investor inquiries: Duncan Learmouth (020) 8047 5540 Anita Kidgell (020) 8047 5542 Alice Hunt (020) 8047 5543 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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