The European Medicines Agency has cleared Roche's RoACTEMRA for the treatment of a rare form of arthritis, polyarticular juvenile idiopathic arthritis (PJIA), in children aged two years and above.
Approved for use alone or in combination with methotrexate (MTX), RoACTEMRA is indicated for children who have not responded to disease-modifying anti-rheumatic drug treatment.
Roche chief medical officer and global product development head Hal Barron said the approval comes earlier than expected, just one month following the positive CHMP opinion.
"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," Barron added.
The data from phase III CHERISH study, which demonstrated the efficacy of RoACTEMRA in improving in signs and symptoms of PJIA, formed the basis for the approval.
Known as ACTEMRA outside of Europe, RoACTEMRA is the first humanised interleukin-6 (IL-6) receptor antagonist used for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
