US regulators have opened the door to GlaxoSmithKline’s first-in-class topical antibiotic Altabax for the treatment of the skin infection impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes.
The drug has been given the all clear for twice daily use over a five-day period in patients aged nine months an above, offering an immediate benefit over rival topical antibacterials which can be used as much as three times daily for up to 12 days, the group claims.
Altabax is the first in a new class of antibacterials called pleuromutilins, and represents the first novel topical antibiotic to be approved by the US Food and Drug Administration in nearly two decades, according to GSK. It works by binding to a site on a sub-unit of the bacterial ribosome, thereby inhibiting protein synthesis. In vitro, the drug has shown no target-specific cross-resistance to other established classes of antibacterials, likely because currently no other antibacterials use the exact same mode of action, GSK says.
"The introduction of Altabax [retapamulin] comes at a time when antibiotic resistance is at an increasingly high level," said Stan Block, President, Kentucky Pediatric and Adult Research. "Altabax provides clinicians with a convenient new means to effectively fight the bacteria that cause impetigo through an effect that is different from other antibiotics. In vitro, this new topical antibiotic has shown a low potential for the development of resistance, possibly because it works in a unique manner compared to other antibiotics."
Earlier this year, the European Medicine's Agency's Committee for Medicinal Products for Human Use gave the thumbs up to Altabax, though a final decision by the Agency has not yet been reached.