FDA grants breakthrough therapy designation for Roche’s Actemra/RoActemra in giant cell arteritis

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation status to Actemra/RoActemra® (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition.

GCA is caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.

In June this year, Roche announced the positive outcome of the Phase III GiACTA study evaluating Actemra/RoActemra in people with GCA. Results showed that Actemra/RoActemra, initially combined with a six month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12 month steroid-only regimen in people with GCA.

Dr Sandra Horning, Roche’s Chief Medical Officer and head of Global Product Development, said: “The FDA Breakthrough Therapy designation for GCA underscores our continued commitment to explore Actemra/RoActemra in autoimmune diseases with significant unmet need.”

Full data will be presented at an upcoming medical meeting in 2016.