The European Commission has granted marketing authorization of the use of Enbrel (etanercept) as the first biologic licensed for treatment in children and adolescents with chronic severe plaque psoriasis. The approval by the commission allows for the treatment of patients between the ages of eight and 171 who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use in November 2008 and is based on the results from the 211 study, the first trial of a biologic treatment in plaque psoriasis patients in this age group. This is the sixth indication for Enbrel which is also approved for use in adult rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, adult psoriatic arthritis and adult psoriasis.
"We are delighted by the news of the European Commission's approval of the use of Enbrel in this younger population which up until now, were unable to access the same treatment options that adults with psoriasis have had for four years," said Andreas Krebs, president, Wyeth Europe. "Enbrel has a long established efficacy and safety record, with 16 years of collective clinical experience. This approval makes Enbrel the first and only biologic psoriasis treatment licensed for children aged eight to 17 and solidifies Enbrel's position as the leading psoriasis treatment."