GlaxoSmithKline (GSK) announced that its new, novel topical antibiotic ALTARGO? (retapamulin ointment, 1%) received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds.
Impetigo is a superficial skin infection most commonly seen in children. The CHMP’s positive opinion will now be proposed for final marketing approval by the European Commission.
“ALTARGO is predicted to have a valuable clinical role in treating uncomplicated skin infections,? said Dr Lynn Marks, Senior Vice President, Infectious Diseases Medicines Development Centre at GSK. ?By providing both efficacy and tolerability in a simple and short treatment regimen, ALTARGO is a favorable treatment option for patients and is an example of GSK?s ongoing commitment to the management and treatment of infectious diseases.”
ALTARGO will be used to treat bacterial infections most commonly caused by Staphylococcus aureus and Streptococcus pyogenes affecting small areas of skin. The impetigo indication is based primarily on the results of a double-blind, placebo-controlled clinical study demonstrating that the efficacy of ALTARGO was superior to placebo in adults and children. In a second pivotal study, ALTARGO was found to provide an effective course of therapy for impetigo compared to another commonly used topical antibiotic, fusidic acid. In two additional Phase III clinical trials, researchers examined the efficacy and safety of ALTARGO versus oral cephalexin for the treatment of infected abrasions, minor cuts and wounds in patients nine months of age and older.
GSK is committed to developing anti-infectives like ALTARGO. A significant need exists for new therapies because antibiotic resistance is at an increasingly high level. Retapamulin belongs to a new class of antibiotics called pleuromutilins and demonstrates a unique mode of action that is different from currently available antibiotics. Due to this unique mode of action, retapamulin exhibits a low potential for the development of resistance in vitro.