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Etanercept Approved in EU for Treatment of Paediatric Psoriasis NEW YORK -- January 12, 2009 -- Etanercept (Enbrel) has been approved by the European Commission for the treatment of chronic severe plaque psoriasis in children aged 8 years and above. "Managing paediatric psoriasis is a great clinical challenge as many therapies are not licensed for children or adolescents or have limited use due to their low tolerability and adverse reactions," said Ruth Murphy, MD, Consultant Dermatologist, Queen's Medical Centre, Nottingham, United Kingdom. "[This] announcement is good news not only for children affected by severe psoriasis, but also for their parents and carers. It will give them confidence that their children are receiving an effective treatment which is well tolerated and has been specifically investigated in children." The approval is based on 48 week study results from a phase 3 study showing that patients treated with etanercept experienced a significant improvement of their psoriasis compared with those treated with placebo. According to physician's assessment, over half the children taking etanercept were clear or almost clear of visible symptoms such as redness, thickness, and scaliness of lesions caused by plaque psoriasis. There were no serious adverse events or serious infections during the 12-week placebo-controlled period and rates of adverse events were similar for etanercept and placebo. During open-label treatment, 3 patients developed 4 serious adverse events. No deaths, cancers, opportunistic infections, tuberculosis, or demyelination events were reported. The most common adverse events observed during the 48-week trial in patients treated with etanercept were upper respiratory tract infection, headache, and nasopharyngitis. SOURCE: PR Newswire on behalf of Wyeth Pharmaceuticals Limited E-mail this page to a friend or colleague! To print, use this version