AbbVie's HUMIRA® (Adalimumab) Approved by European Commission to Treat Children and Adolescents with Severe Chronic Plaque Psoriasis
– HUMIRA is the only Biologic Approved in Europe for Children and Adolescents from Four Years of Age with Severe Chronic Plaque Psoriasis –
NORTH CHICAGO, Illinois, April 1, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has granted marketing authorization for HUMIRA® (adalimumab) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. With the EC decision, HUMIRA now has approval for use in this indication in all member states of the European Union.
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"Several treatments have been shown to be effective in subgroups of patients with pediatric psoriasis. However, a limited body of supporting data is available. The approval of adalimumab is an important milestone in particular for children with severe disease because it extends the armamentarium of the physicians who are working to reduce the burden of this chronic disease in this sensitive young patient population," said Marieke M.B. Seyger, MD, PhD, Associate Professor of Dermatology, Radboud University Medical Center in Nijmegen, Netherlands.
The marketing authorization is based on the positive results of a Phase 3 study, which will be presented at an upcoming medical meeting. Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 851,083 patients worldwide1 across 11 globally approved indications.2
"With the approval from the European Commission, HUMIRA is now the only biologic approved in Europe to treat children with this condition starting at four years of age, offering an important new option for physicians treating pediatric plaque psoriasis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This new indication contributes to the increasingly broad spectrum of indications for HUMIRA, and supports its strong record of efficacy and safety in treating pediatric populations who are managing challenging chronic diseases."