The European Medicines Agency has expanded approval for Roche's RoActemra to cover the treatment of children with polyarticular juvenile idiopathic arthritis.
The regulator has decreed that RoActemra (tocilizumab) can be used to treat patients two years of age and older who have not responded adequately to treatment with methotrexate. The drug can be given alone or in combination with MTX.
PJIA is a form of juvenile idiopathic arthritis (JIA) which affects approximately 100 in every 100,000 children, and PJIA accounts for around 30% of cases. The latter is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints, such as those in the hands and feet.
The Swiss major noted that this is the second paediatric indication for RoActemra and follows a 2011 approval for systemic juvenile idiopathic arthritis (sJIA). Hal Barron, Roche’s chief medical officer, said the approval comes earlier than expected, just one month following the positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). He added that “we can now quickly provide these young patients with this medicine that we hope will help them to better manage their disease symptoms and allow them to pursue an active lifestyle".
RoACTEMRA, an interleukin-6 receptor antagonist, is approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.