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GlaxoSmithKline (GSK) (Jobs) Receives Not Approvable Letter From FDA on Advair(R) 500/50 for COPD


8/8/2007 9:05:46 AM

RESEARCH TRIANGLE PARK, N.C., Aug. 8 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK - News) announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair DiskusĀ® (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).

The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair 250/50 strength.

"We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this year," said Katharine Knobil, M.D., Vice-President of Respiratory Clinical Development for COPD at GSK. "The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward."

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 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 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, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.

For company information, visit GSK at www.gsk.com

Source: GlaxoSmithKline



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