FDA approves subcutaneous Actemra for patients 2 years and older with systemic juvenile idiopathic arthritis. Genentech/Roche

Genentech,has announced that the FDA has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with SJIA.

In 2011, FDA approved the intravenous (IV) formulation of Actemra for patients two years of age and older with active SJIA. SJIA is the rarest form of juvenile idiopathic arthritis (JIA), a chronic arthritic disease affecting children. JIA affects nearly 300,000 children in the U.S., of which SJIA accounts for around 10 percent.

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 (PK)/pharmacodynamic (PD) bridging study designed to determine the appropriate dosing regimen of Actemra SC across a range of body weights (BWs) in children with SJIA. The 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 <30 kg received 162 mg of actemra every two weeks or 10 days and sjia patients weighing 30 kg received 162 mg of actemra every week for 52 weeks. model-computed pk and pd parameters and safety were assessed.>