Posted by Michael Wonder on 14 Sep 2018
FDA approves subcutaneous formulation of Actemra for use in active systemic juvenile idiopathic arthritis, a rare form of juvenile arthritis
13 September 2018 - Genentech announced today that the U.S. FDA 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.
Actemra can be given alone or in combination with methotrexate in patients with systemic juvenile idiopathic arthritis (SJIA). In 2011, FDA approved the intravenous formulation of Actemra for patients two years of age and older with active SJIA.
The approval is based on data from the JIGSAW-118 study, a 52-week, open-label, multi-centre, Phase 1b pharmacokinetic /pharmacodynamic bridging study designed to determine the appropriate dosing regimen of Actemra subcutaneous across a range of body weights in children with SJIA.
