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news.Wyeth Pharmaceuticals has announced that the European Committee for Medicinal Products for Human Use has issued positive recommendation for the approval of Enbrel as a treatment for children aged eight years and over and adolescents with severe plaque psoriasis.
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The recommendation by the Committee for Medicinal Products for Human Use (CHMP) is based on results from the first randomized placebo-controlled trial of a biologic treatment in children aged 17 and under. Results from the study showed that patients treated with Enbrel experienced a significant improvement of their plaque psoriasis compared to those treated with placebo.
If approved by the European Commission, following the committee’s recommendation, Enbrel will become the first biologic treatment indicated for severe psoriasis in children and adolescents.
Enbrel is currently approved in the EU for the treatment of moderate-to-severe plaque psoriasis in adults, as well as for ankylosing spondylitis, psoriatic arthritis, moderate to severe rheumatoid arthritis in adults, and polyarticular juvenile idiopathic arthritis in children.
Stevo Knezevic, chief medical officer of Wyeth Europa, said: “Psoriasis can be a distressing disease at any age. A third of psoriasis patients first see signs of the disease well before the age of 16 and there are currently limited effective treatment options available with approved dosing regimens for children and adolescents. We are, therefore, encouraged by the positive recommendation from the CHMP for the approval of Enbrel for use in the pediatric population.”