FDA declines Glaxo on higher Advair dose

(Adds Glaxo comment, background, share move)

NEW YORK, Aug 8 (Reuters) - GlaxoSmithKline Plc (GSK.L) said on Wednesday that U.S. health regulators declined to approve a higher strength version of its inhaled Advair Diskus for the treatment of chronic obstructive pulmonary disease

(COPD).

Europe's largest drugmaker said it received a non-approvable letter from the Food and Drug Administration for the 500/50 strength version of the medicine, even after an advisory panel had unanimously recommended its approval.

The 250/50 Advair Diskus was approved in 2003 for maintenance treatment of airflow obstruction in COPD patients.

The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations, Glaxo said.

Glaxo has sought the expanded approval of the higher strength medicine --known chemically as fluticasone propionate and salmeterol inhalation powder -- for COPD, including chronic bronchitis and emphysema.

"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, Glaxo's vice president of respiratory clinical development for COPD, in a statement.

"The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations," she added, referring to results of a three-year, 6,000-patient study that was reviewed by the committee and submitted to the FDA.

COPD-related exacerbations are generally 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.

Glaxo said it would meet with the FDA to discuss the agency's concerns in more detail and determine the next steps it will take in efforts to get the higher strength Advair Diskus approved for sale in the United States.

"We are committed to working with the FDA to address any questions they have and to pursue a way forward," Knobil said.

Glaxo shares rose 30 cents to $52.78 on the New York Stock Exchange and were off less than 1 percent in London trading.

(Reporting by Bill Berkrot, editing by Dave Zimmerman/Jeffrey Benkoe)

((Reuters Messaging: bill.berkrot.reuters.com@reuters.net phone 646 223-6030)) Keywords: GLAXO ADVAIR/

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