Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older. Actemra can be given as monotherapy or in combination with methotrexate.
This approval marks the second Actemra indication in children and is the first FDA approval for the treatment of PJIA in approximately five years. The expanded indication for Actemra was based on positive Phase III results of the CHERISH study in children with PJIA, which demonstrated that Actemra-treated patients experienced clinically meaningful improvement in signs and symptoms of PJIA.
PJIA is a form of juvenile idiopathic arthritis (JIA), characterised by inflammation in five or more joints, usually affecting the hands and feet. Approximately 100 in every 100,000 children suffer from JIA, with PJIA accounting for approximately 30%.
"Polyarticular juvenile idiopathic arthritis is a rare, debilitating condition in children that worsens over time," said Hal Barron, MD, chief medical officer and head of global product development, in a press statement. "We are pleased to offer Actemra to doctors and parents of children aged two or older as an important medicine to help improve the signs and symptoms of this often painful disease."
Actemra is the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The clinical development program for RA included five Phase III clinical studies, which enrolled more than 4000 RA patients from 41 countries, including the US. Actemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA).