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EC approves Roche’s juvenile arthritis drug

Roche’s RoACTEMRA drug has been approved as a treatment of active systemic juvenile idiopathic arthritis

The European Commission has approved the use of Roche's RoACTEMRA (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients two years of age and older who have responded inadequately to previous therapies.

sJIA is the rarest form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis (JRA). The disease affects about 10 to 20 per cent of children with JIA, with the peak age of onset between 18 months and two years, although the disease can persist into adulthood. sJIA has a 2 to 4 per cent overall estimated mortality rate and accounts for almost two-thirds of all deaths among children with arthritis.

RoACTEMRA, known as ACTEMRA outside of Europe, can be given alone or in combination with methotrexate in patients with sJIA.

Dr Hal Barron, chief medical officer and head of global product development, said: “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”

RoACTEMRA is currently used for the treatment of adult rheumatoid arthritis in people who have either responded to, or who were intolerant to, previous therapies. It is the only licensed biologic treatment to target the interleukin-6 (IL-6) pathway, which plays a pivotal role in sJIA pathogenesis.

8th August 2011

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