Breakthrough designation for Roche's Actemra in giant cell arteritis

Swiss pharma giant Roche (ROG: SIX) has moved closer to gaining an additional indication for its rheumatoid arthritis drug Actemra (tocilizumab) – this time for giant cell arteritis (GCA).

The US Food and Drug Administration has granted the biologic, which is marketed as RoActemra in Europe, Breakthrough Therapy designation for GCA, a chronic, potentially life-threatening autoimmune condition caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.

Sandra Horning, chief medical officer and head of global product development at Roche, said: “The FDA breakthrough therapy designation for GCA underscores our continued commitment to explore Actemra in autoimmune diseases with significant unmet need.