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GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists
Date:12/11/2008

WASHINGTON, Dec. 11 /PRNewswire-FirstCall/ -- The following is GlaxoSmithKline's (NYSE: GSK) statement regarding recommendations of a combined Advisory Committee to the FDA on the use of asthma medicines containing long-acting beta agonists, including GSK's Serevent(R) (salmeterol) and Advair(R) (salmeterol/fluticasone proprionate).

"We welcome the committee's endorsement of Advair as a safe and effective treatment for asthma in adults and children," said Dr. Ellen Strahlman, Chief Medical Officer for GSK. "We believe this recommendation is consistent with national treatment guidelines -- based on evidence and developed by experts -- that support the combination of a LABA and ICS as a preferred treatment for children and adults with persistent asthma. We will continue to work with physicians to encourage broader understanding of national guidelines for appropriate use."

"Serevent, when used with an ICS, is an important treatment option for some patients as outlined in national guidelines. We are confident that our proposed new labeling, medication guide and risk management plan would help physicians safely manage the appropriate use of Serevent in conjunction with an ICS," Dr. Strahlman said. "We are concerned that -- if the FDA adopts the panel's recommendation on Serevent -- it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma."

GSK is committed to continuing discussions with the Agency as it determines next steps following the Advisory Committee meeting.

GSK conducted an analysis of more than 200 clinical studies that included more than 100,000 patients, presenting the following information to the committees:

-- The clinical and observational data presented by GSK demonstrated better overall asthma contr
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SOURCE GlaxoSmithKline
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