Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for giant cell arteritis, a form of vasculitis. 

Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition that is more likely to affect women than men. In June 2016, the Company announced positive data from the Phase 3 GiACTA study that evaluated Actemra in patients with giant cell arteritis. In the study, Actemra combined with a 6-month glucocorticoid regimen was more effective at sustaining remission through Year 1 vs. a 6- or 12-month steroid-only regimen in patients with giant cell arteritis. 

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Actemra, a humanized interleukin (IL)-6 receptor antagonist is already indicated to treat adults with moderately to severely active rheumatoid arthritis who have used 1 or more disease-modifying antirheumatic drugs (eg, methotrexate) that was not adequate. Actemra as an intravenous (IV) formulation is indicated to treat patients with polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) in patients ≥2 years. 

A Breakthrough Therapy designation aids in expediting the development and review of medicines with early evidence of potentially clinical benefit in serious diseases. 

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