GSK Statement on FDA Proposed Labeling Change for Serevent and Advair
GSK Statement on FDA Proposed Labeling Change for Serevent and Advair
RESEARCH TRIANGLE PARK, N.C., November 18, 2005 -- GlaxoSmithKline disagrees with the FDA's proposed product labeling changes for Serevent and Advair, because they are inconsistent with established NIH treatment guidelines and the standard of care for asthma treatment, which could put many patients at risk of uncontrolled asthma.
The proposed changes are a departure from recent outcomes of a July 2005 FDA advisory committee meeting that reinforced the favorable benefit-to-risk profile of both medicines. The advisory committee supported the use of long- acting beta-agonists (LABA) in combination with inhaled corticosteroids (ICS) and proposed no new restrictions. Since that time, there have been no new data on the 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 the FDA's proposed labeling changes," said Dr. Kathy Rickard, GSK Vice President Clinical Development and Medical Affairs, respiratory medicine in the U.S. "These proposed labeling changes would reserve the most effective asthma treatment -- the combination of inhaled corticosteroids and long-acting beta agonists -- until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations and potentially death."
GSK believes sufficient safety information about these medicines is already in the labels to help guide physicians about their appropriate use. However, we will work with FDA to address the differences of opinion about how best to communicate the benefit risk profile of these medicines for optimal patient care.
The current labeling of Advair is consistent with asthma treatment guidelines established by the NIH and supported by GSK. These guidelines position ICS and LABA as first-line therapy for moderate to severe persistent asthma, and are supported by a significant body of evidence.
Asthma is a chronic condition that affects 20 million Americans, causing about 5,000 deaths each year. The risk of uncontrolled asthma is significant and could cause life-threatening situations requiring emergency room visits, hospitalization and even causing death. African Americans and Hispanics are three to five times more affected by asthma in the U.S.
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 of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting beta2-agonist. It is not indicated 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 treatment of asthma in patients 4 years of age and older. Advair Diskus is NOT indicated for the relief of acute bronchospasm.
Source: GlaxoSmithKline
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