GlaxoSmithKline announces Altargo® receives positive opinion in Europe for treatment of impetigo and other skin infections

London, UK - GlaxoSmithKline (GSK) today 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.



About Impetigo

Impetigo is a highly contagious bacterial infection of the top layers of the skin. It is most common among children two to six years of age. Cuts, scratches, insect bites or other dermatological conditions, notably eczema, can leave skin vulnerable to bacterial infection, especially with Staphylococcus aureus or group A Streptococcus. The infection causes sores which fill with pus before breaking open and producing the characteristic honey-coloured or yellowish brown crusts. Impetigo can be spread by direct contact with wounds, sores or nasal discharge from an infected person, and scratching may facilitate the spread of the infection.[1]


About ALTARGO

ALTARGO is a new antibiotic that belongs to a class of antibiotics called pleuromutilins and demonstrates a unique mode of action that is different from currently available antibiotics. ALTARGO is the first pleuromutilin to receive a positive opinion for use in humans. ALTARGO demonstrates no target-specific cross-resistance with other antimicrobial drugs, possesses excellent in vitro activity against bacteria that have become resistant to other classes of antibiotics, and exhibits a low potential for the development of resistance in vitro.


In these clinical studies in which a total of 2150 patients with superficial skin infections applied ALTARGO, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.


About Pleuromutilins

Pleuromutilins represent a class of antibacterial agents that are potent and highly selective inhibitors of the bacterial protein synthesis machinery and, by virtue of their novel mechanism of action, possess excellent in vitro activity against bacteria that have become resistant to other classes of antibiotics.


About GlaxoSmithKline

GlaxoSmithKline has an established heritage in the development of novel anti-infectives to meet clinical needs. These products include the topical antibacterial agent Bactroban® (mupirocin) as well as the oral agent Augmentin® (amoxicillin/clavulanate potassium). These products have not only helped to widen the range of bacterial infections that can be successfully treated, but also to combat emerging bacterial resistance to existing agents. GSK is committed to the discovery, development, and commercialisation of innovative, potent antibacterials. Our approach includes in-house research using leading technologies, as well as actively seeking in-licensing opportunities and partnerships.


GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Additional information about GlaxoSmithKline can be found online at www.gsk.com.