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news.The European Commission (EC) has granted marketing authorization for AbbVie's Humira (adalimumab) to treat children and adolescents with severe chronic plaque psoriasis.
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The drug is indicated for use 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 latest approval, Humira is now marketed for use in this indication in all member states of the European Union (EU).
The approval is based on the positive results of a Phase III trial, which will be reported at an upcoming medical meeting.
Currently, Humira has been approved in more than 87 countries and is being used to treat more than 851,083 patients worldwide.
AbbVie Research and Development executive vice president and chief scientific officer Michael Severino said: "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.
"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."
Humira is indicated to treat severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s disease and moderate to severely active ulcerative colitis.