GSK Announces FDA Approval of Antibacterial Ointment

April 13, 2007

GlaxoSmithKline (GSK) announced that the FDA has approved its antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection.

Altabax represents the first new class of prescription topical antibacterials to be approved by the FDA in nearly two decades, GSK said. Altabax is indicated for use twice daily for a five-day period in patients older than 9 months. Other prescription topical antibacterials are used as often as three times daily for up to 12 days. Impetigo is a highly contagious infection of the top layers of the skin and is most common among children ages 2 to 6 years old, according to GSK.

In making its decision for approval, the FDA reviewed Phase III data examining the safety and efficacy of Altabax twice daily for five days versus placebo ointment in the treatment of impetigo. The randomized, double-blind, multicenter, placebo-controlled study enrolled a total of 210 adults and children with impetigo, of which 139 received topical Altabax. Culture-proven pathogens were seen in 82 percent of these patients, and the most common bacteria causing these infections were S. aureus and S. pyogenes.

The findings showed that after five days of treatment, the rates of clinical success, defined as response of impetigo at end of therapy wherein no further antibacterial treatment was needed, were greater in the Altabax group (85.6 percent) than in the placebo group (52.1 percent). Microbiological success rates were also greater in the Altabax group (91.2 percent) than in the placebo group (50.9 percent). Altabax was generally well tolerated throughout the study.