Genentech: Actemra Meets Endpoints In Phase III GiACTA Study

(RTTNews) - Genentech, a member of the Roche Group (RHHBY.PK), announced positive results from the Phase III GiACTA study, which evaluated Actemra (tocilizumab) in people with giant cell arteritis. GiACTA met its primary and key secondary endpoint, demonstrating that Actemra - initially in combination with a six-month steroid (glucocorticoid) taper - enabled significantly more patients to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone. No new safety signals were observed.

Genentech said, data from the analysis will quantify Actemra's long-term safety and maintenance of efficacy beyond one year, as well as any potential long-term steroid sparing effects. A 104-week open label extension study from GiACTA is still ongoing. Actemra has been granted Breakthrough Therapy Designation for GCA by the FDA.