AbbVie’s Humira Wins EU Approval for Severe Chronic Plaque Psoriasis in Children, Teens
The European Medicines Agency has greenlighted AbbVie’s Humira for the treatment of severe chronic plaque psoriasis in children and adolescents who have had an inadequate response to or are poor candidates for topical and photo therapies.
Humira (adalimumab) is now the only biologic approved in Europe to treat children with this condition beginning as young as four years of age, says Michael Severino, AbbVie’s executive vice president of research and development.
The new indication adds to the increasingly broad range of indications for Humira, which AbbVie is seeking to get as much mileage as possible from before its patents start expiring next year. In addition to the severe chronic plaque psoriasis, the therapy’s pediatric uses in Europe are enthesitis-related arthritis, severe plaque psoriasis, severe Crohn's disease, and active juvenile idiopathic arthritis in patients who responded inadequately to prior therapy.
In adults, Humira is indicated for the treatment of 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. It is approved for use in pediatric patients.
Worldwide sales of Humira were $12.5 billion last year. The biologics’ U.S. patent is set to expire in December 2016 and its EU patent runs out in April 2018. — Jonathon Shacat