EU Approves New Use for AbbVie’s Humira

AbbVie reports 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.

Since first gaining approval 12 years ago, Humira has been approved in more than 87 countries. It is currently has approval for 11 indications on a global basis. Humira is approved for use in moderate to 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. Humira is approved in pediatric patients for use in enthesitis-related arthritis, severe plaque psoriasis, severe Crohn’s disease, and active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy.

Humira is AbbVie’s top-selling drug. It had 2014 sales of $12.5 billion, accounting for 63%,of the company’s 2014 sales of $19.960 billion.


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