Posted by Michael Wonder on 22 Jul 2017
AbbVie receives CHMP positive opinion for Humira (adalimumab) for the treatment of paediatric patients with chronic non-infectious anterior uveitis
21 July 2017 - The CHMP opinion is based on results from SYCAMORE, an investigator-initiated clinical trial.
AbbVie announced today that the European CHMP of the EMA has granted a positive opinion for Humira (adalimumab) for the treatment of chronic non-infectious anterior uveitis in paediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
The CHMP opinion is based on results from the SYCAMORE clinical trial, a randomised controlled study of the clinical effectiveness and safety of Humira combined with methotrexate versus methotrexate plus placebo for the treatment of active JIA-associated uveitis. It was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. The Independent Data Safety and Monitoring Committee recommended unmasking the trial early after 90 randomised patients with active JIA-associated uveitis showed that Humira combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure than placebo.
