14 September 2018 - - The US Food and Drug Administration has approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients two years of age and older, US-based biotechnology company Genentech said.

Actemra can be given alone or in combination with methotrexate in patients with SJIA.

Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).

In 2011, FDA approved the intravenous formulation of Actemra for patients two years of age and older with active SJIA.

SJIA is the rarest form of juvenile idiopathic arthritis, a chronic arthritic disease affecting children.1 JIA affects nearly 300,000 children in the US, of which SJIA accounts for around 10%. 

SJIA is characterized by inflammation in one or more joints, and a daily, spiking fever for at least two weeks, which may be accompanied by a skin rash.

Other symptoms may include anemia, enlargement of the liver or spleen, and inflammation of the lining of the heart and/or lungs.

The approval is based on data from the JIGSAW-118 study, a 52-week, open-label, multicenter, Phase 1b pharmacokinetic /pharmacodynamic bridging study designed to determine the appropriate dosing regimen of Actemra SC across a range of body weights in children with SJIA.

This study enrolled 51 patients aged one to 17 years with SJIA and inadequate response to NSAIDs and corticosteroids who were either Actemra naive or were receiving Actemra IV with adequate disease control.

Actemra SC was administered open label according to a body weight –based dosing regimen: SJIA patients weighing