On August 8, 2007, GlaxoSmithKline (GSK) announced that its application for the approval of a higher-strength Advair Diskus was denied by the Food and Drug Administration (FDA). The agency sent GSK a nonapprovable letter three months after an advisory committee unanimously recommended that the drug be approved.

Low- and middle-strength versions of Advair Diskus are approved by the FDA, but the agency questioned how the proposed higher-strength version compares to the middle-strength version.

Advair Diskus is prescribed to treat patients with chronic obstructive pulmonary disease (COPD). It has also been prescribed to treat asthma, though doctors say it may not be the best option.

Dr. Miles Weinberger, professor of pediatrics at the University of Iowa, said in an August 24, 2006 letter to the New England Journal of Medicine that, “some patients are receiving the combination drug (Advair) but don’t actually need it, and there is at least a small sub-group of patients for whom previous research showed the salmeterol-steroid combination has a very negative, rather than beneficial, effect.”

FDA guidelines are also advising patients not to use drugs like Advair as first-resort medications to control asthma. Recently, GSK has been criticized for its marketing of the drug, which may have led patients to believe Advair is safe to use as a regular asthma treatment.

The higher-strength version of Advair, called Advair 500/50, was unanimously recommended for approval by an FDA advisory board on May 1, 2007.

“The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations,” read a GSK statement, referring to worsening symptoms that require medical intervention. “We believe in the strength of our data.”

Sources: “FDA denies GSK lung drug,” Wall Street Journal, August 9, 2007; Catherine Larkin and Andrea Gerlin, “Glaxo’s Advair rejected by US FDA for an added use,” Bloomberg, August 8, 2007; “Choked out? – GlaxoSmithKline’s asthma drug Advair Diskus 500/50 gets not approvable letter,” RTT News, August 8, 2007; “Doctors renew warning on asthma drugs,” Healthfinder.gov, August 23, 2006.