Roche’s rare arthritis drug approved for use in EU

The European Medicines Agency has approved Roche's rare arthritis drug, RoACTEMRA, for use in Europe. This approval comes only a month after EMA's Committee for Medicinal Products for Human Use (CHMP) recommended approval for extended use of RoActemra, also known as Actemra outside of Europe.

RoACTEMRA has been approved to treat children with polyarticular juvenile idiopathic arthritis (PJIA), a rare, chronic and debilitating form of childhood arthritis. The medicine can be used to treat patients two years of age and older who have not responded adequately to treatment with methotrexate (MTX), a disease-modifying anti-rheumatic drug. RoACTEMRA can be used alone or in combination with MTX.

PJIA is a form of juvenile idiopathic arthritis (JIA), which affects approximately 100 in every 100,000 children. PJIA accounts for 30% of cases.

"This 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."

Hal Barron, MD, Roche's Chief Medical Officer and Head of Global Product Development.