14 May 2018 - Genentech announced today that the U.S. FDA has approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis in patients two years of age and older. 

Actemra can be given alone or in combination with methotrexate in patients with polyarticular juvenile idiopathic arthritis (PJIA). In 2013, FDA approved the intravenous formulation of Actemra for patients two years of age and older with active PJIA.

The approval is based on data from the JIGSAW-117 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 PJIA. The study enrolled 52 patients aged one to 17 years with PJIA and previous inadequate response or intolerance to methotrexate 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 (BW)–based dosing regimen: PJIA patients weighing <30 kg received 162 mg of Actemra every three weeks and PJIA patients weighing ≥30 kg received 162 mg of Actemra every two weeks for 52 weeks. Model-computed PK and PD parameters, and safety were assessed.

Read Genentech press release