Press Release: FDA Panel Says GlaxoSmithKline's Advair Doesn't Boost COPD Survival

FDA Panel Says GlaxoSmithKline's Advair Doesn't Boost COPD Survival RESEARCH TRIANGLE PARK, N.C., May 1 -- An Advisory Committee to the U.S. Food and Drug Administration (FDA) today unanimously agreed (11 to 0) that GlaxoSmithKline's Advair Diskus(R) 500/50 (fluticasone propionate and salmeterol inhalation powder) demonstrated a significant reduction in the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the U.S. Additionally, they voted unanimously (11 to 0) that Advair 500/50 provides substantial advantages over salmeterol in the treatment of patients with COPD. COPD-related exacerbations are typically defined as worsening symptoms that require medical intervention. A high rate of exacerbations is associated with significant disease progression, including a rapid decline in lung function and an increased risk of hospitalization and death. "We are pleased that the Advisory Committee recognized the important benefit that Advair 500/50 has shown in the management of this serious disease," said Katharine Knobil, M.D., Vice-President of Respiratory Clinical Development for COPD at GSK. "Reducing exacerbations is one of the most important goals for patients with COPD, especially since they can be precursors to an overall decline in a patient's health." The Advisory Committee reviewed data from the landmark TORCH study (TOward a Revolution in COPD Health) -- currently the largest COPD study and the first to investigate whether a medication can affect both exacerbations and survival -- and other supporting studies. GSK submitted a supplemental new drug application to the FDA in October 2006 seeking marketing approval and expanded labeling for Advair 500/50 based on these studies. The Advisory Committee vote was 9 to 2 that the data presented did not provide substantial evidence to support the survival benefit, and that further data may be needed. They also recommended additional data to better understand the increased incidence of pneumonia among COPD patients treated with inhaled corticosteroids. "We believe in the strength of the TORCH study and believe that the data show that Advair 500/50 provides important benefits for patients with COPD, including a reduction in the risk of dying. Therefore, we remain committed to working with the FDA as it reviews the supporting data from our clinical program" Dr. Knobil added. Advair Diskus(R) 250/50 was approved in 2003 for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. The Advisory Committee recommendations go to the FDA for its consideration in evaluating the application for Advair 500/50 for COPD, including chronic bronchitis and emphysema. Today's recommendations do not affect the existing indication for Advair Diskus 250/50 for COPD associated with chronic bronchitis nor the medicine's indications for the treatment of asthma. COPD is a progressive, life-threatening lung disease that primarily includes chronic bronchitis and emphysema. COPD affects as many as 20 million Americans and is a major cause of illness, death and the use of health care resources. About Advair in COPD Advair 250/50 is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. Advair does not replace fast-acting inhalers to treat sudden symptoms. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. Patients with COPD often have multiple risk factors for reduced bone mineral density. Advair Diskus may increase this risk; therefore, bone mineral density assessment is recommended prior to starting Advair Diskus and periodically thereafter. Long-term use of inhaled corticosteroids, including Advair Diskus, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered. For more information about Advair please visit http://www.gsk.com. About GlaxoSmithKline Advair was developed and is marketed by GlaxoSmithKline, a research based pharmaceutical company and a world leader in respiratory care. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information please visit http://www.gsk.com.

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