Humira approved for paediatric use
The European Commission says the drug can be used on children to treat chronic non-infectious anterior uveitis
Biopharmaceutical company AbbVie has secured approval of humira, which is more commonly known as adalimumab, for the treatment of chronic non-infectious anterior uveitis in children.
The approval allows the drug to be used on those over the age of two who have had “an inadequate response to or are intolerant to conventional therapy,” the company confirmed.
Approval was sought and secured based on the results of the SYCAMORE clinical trial, AbbVie said. The study found that adalimumab, combined with methotrexate, significantly delayed the time to treatment failure when compared to methotrexate with a placebo in children with JIA-associated uveitis.
Principle investigator on the study, Professor Athimalaipet Ramanan, highlighted: “Paediatric uveitis is a debilitating and potentially blinding condition...these results demonstrate adalimumab has the potential to help many children who have failed standard treatments to preserve their eyesight from the ocular complications associated with chronic non-infectious anterior uveitis.”
The approval means adalimumab is the only approved biological treatment option for this purpose in those aged two and over across the EU.
UK medical director of AbbVie, Alice Butler, said: “This approval marks an important milestone for paediatric uveitis patients who, up until this point, had no licensed biologic treatment options for them.
“The label expansion for adalimumab is a further step in AbbVie's dedication to addressing the unmet needs for both adult and paediatric patients living with serious immune-mediated inflammatory diseases.”
Image credit: Flickr/Dr Hitesh K Patel