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New use cleared for Genentech arthritis drug

The US Food and Drug Administration has approved Genentech's Actemra for the new indication of the treatment of active systemic juvenile idiopathic arthritis, a rare paediatric form of arthritis

The US Food and Drug Administration (FDA) has granted approval for Genentech's marketed rheumatoid arthritis drug Actemra (tocilizumab) for the new indication of the treatment of active systemic juvenile idiopathic arthritis (SJIA), a rare paediatric disease that causes severe inflammation throughout the body and can be deadly.

The interleukin-6 receptor blocker has been approved for use alone or in combination with methotrexate in children ages 2 years and older. It is the first approved therapy for children with SJIA, which is similar to other forms of juvenile idiopathic arthritis but is characterised by systemic and inflammatory features including spiking fevers and rash.

Juvenile idiopathic arthritis affects about to 2 per 1,000 children, with SJIA making up about 10 per cent of those cases.

Actemra won US approval in early 2010 for treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumour necrosis factor antagonist therapies.

The new paediatric approval was based on a 112-patient clinical study in which subjects with SJIA received either Actemra infusions or placebo infusions every two weeks. The subjects were between the ages of two and 17 years and had either had inadequate response to nonsteroidal anti-inflammatory drugs and corticosteroids or were unable to take them.

Eighty-five per cent of the children in the Actemra group showed at least 30 per cent improvement in the American College of Rheumatology's JIA efficacy variables, along with absence of fever in the preceding seven days. Only 24 per cent of patients receiving placebo met these same goals.

Genentech, a wholly owned member of the Roche Group, also hopes to expand the adult indication to include earlier lines of RA therapy. The company said it is working on establishing the clinical benefit and safety of Actemra in earlier lines of therapy through a large pharmacovigilance programme, including a risk-management programme and global clinical and post-marketing studies.

18th April 2011

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