GlaxoSmithKline has received the backing of a panel of European regulators for Altargo, the firm’s new treatment for impetigo and other skin infections.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending to grant a marketing authorisation for Altargo (retapamulin) for impetigo and infected small lacerations, abrasions or sutured wounds. Impetigo is a highly contagious bacterial infection of the top layers of the skin that is most common among children aged two to six.
GSK noted that Altargo belongs to a class of antibiotics called pleuromutilins and “demonstrates a unique mode of action that is different from currently available antibiotic.” The CHMP’s positive opinion is based on the benefits shown in randomised, controlled studies in which retapamulin achieved similar clinical success rate to comparative therapies (fusidic acid for impetigo and cephalexin for secondary infected traumatic lesions).
Also benefiting from a positive opinion by the CHMP was Bristol-Myers Squibb's Orencia (abatacept), which received the committee’s backing as a treatment for moderate to severe rheumatoid arthritis. The benefits with Orencia have been shown in studies in which abatacept combined with methotrexate achieved higher clinical success rates compared to placebo and methotrexate, the CHMP noted.