European Commission has approved Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis.- Genentech + Roche.
Roche has announced that the European Commission (EC) has approved Actemra/RoActemra (tocilizumab in its subcutaneous version,) 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.
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 FDA and New Zealand’s Medsafe.
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