Roche receives EU approval for Actemra/RoActemra in giant cell arteritis

Roche has announced that its drug Actemra/RoActemra has been approved in Europe for the treatment of giant cell arteritis.

The therapy has become the first therapy approved by the European Commission for this chronic and potentially life-threatening autoimmune condition, which is characterised by a thickening of the blood vessels in the head and neck, leading to blindness and a risk of permanent organ damage.

Data from the phase III GiACTA study showed that a weekly dose of Actemra/RoActemra, initially combined with a six-month steroid taper, significantly increased the proportion of patients achieving sustained remission at one year compared to steroids alone.

Actemra/RoActemra was also approved in this indication by regulators in the US and New Zealand earlier this year.

Dr Sandra Horning, Roche's chief medical officer and global head of product development, said: "As the first effective non-steroid therapy for GCA, Actemra/RoActemra has the potential to fundamentally change how this condition is treated."

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