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European Commission approves Actemra/RoActemra for giant cell arteritis
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Actemra/RoActemra has been approved by the European Commission for the treatment of giant cell arteritis, according to a Roche press release.
The anti-IL-6 receptor biologic Actemra/RoActemra (tocilizumab) was approved for giant cell arteritis (GCA) based on the outcome of the GiACTA phase 3 randomized, double-masked, placebo-controlled trial, the release said. In the trial, Actemra/RoActemra combined with a 6-month steroid taper significantly increased the number of patients who had sustained remission at 1 year (56%) compared with a 6-month steroid taper alone (14%) (P < .0001).
“In giant cell arteritis the blood vessels in the head and neck, as well as the aorta, become inflamed and thickened, reducing blood flow. This can result in devastating symptoms, including irreversible blindness, and puts patients at risk of permanent organ damage,” Sandra Horning, MD, Roche’s chief medical officer and global head of product development, said in the release. “As the first effective nonsteroid therapy for GCA, Actemra/RoActemra has the potential to fundamentally change how this condition is treated.”
Actemra/RoActemra was approved by the FDA for the treatment of GCA in May.