EMA Recommends New Use for AbbVie’s HumiraBy
AbbVie reports that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for Humira (adalimumab) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age. If granted marketing authorization by the European Commission, Humira may become the first treatment available for 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.
Humira is AbbVie’s top-selling drug with 2014 sales of $12.5 billion. Since first gaining approval 12 years ago,it has been approved in more than 87 countries across 10 globally approved indications. The drug is approved for use in moderate to severe rheumatoid arthritis, active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy, 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.