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GlaxoSmithKline to respond to FDA request on LABAs

 

PHILADELPHIA  March 5, 2008 - GlaxoSmithKline [NYSE: GSK] said it is preparing a response to the US Food and Drug Administration’s (FDA) request for clinical study data on long acting beta-agonists (LABAs).  The FDA request, made in January 2008, follows a Pediatric Advisory Committee which met on November 28, 2007, and which recommended another advisory committee review of safety data on all medicines of the LABA class.

 

In July of 2005, the FDA conducted an extensive review of the safety data related to salmeterol and the outcome confirmed the importance of this medication in the treatment of asthma.  GSK believes the product labels reflect appropriate safety information for patients four years of age and older.GSK is aware of no new safety information that changes the benefit-risk evaluation of Serevent or Advair.

 

GSK has confidence in the proven safety profile of Advair and Serevent when these medicines are used appropriately in accordance with their labels and in line with national treatment guidelines. Overall data on salmeterol-containing products confirm the favorable safety and efficacy profile of Serevent and Advair.

 

The risk of untreated and uncontrolled asthma is significant and can be life-threatening. Advair and Serevent, when taken as indicated, help people with asthma control their symptoms.  National and international evidence-based asthma treatment guidelines recommend the use of inhaled long-acting beta-agonists, like salmeterol, in conjunction with inhaled corticosteroids for children and adults with moderate to severe persistent asthma.