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

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The FINANCIAL — Roche announced on September 22 that the European Commission (EC) has approved Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition.

Actemra/RoActemra is the first therapy approved for the treatment of GCA in Europe, according to Roche.

“In giant cell arteritis (GCA) 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,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Global Head of Product Development. “We are delighted that Actemra/RoActemra has been approved for the treatment of GCA in Europe. As the first effective non-steroid therapy for GCA, Actemra/RoActemra has the potential to fundamentally change how this condition is treated.”

The European approval was based on the outcome of the phase III GiACTA study, which 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 (56%; p <0.0001) compared to a six-month steroid taper given alone (14%). The results of the phase III GiACTA study were recently published in the New England Journal of Medicine in July 2017.
In May 2017 Actemra/RoActemra was approved for the treatment of GCA by the US Food and Drug Administration (FDA) and New Zealand’s Medsafe.

 

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