Roche: GCA drug approval in Europe.

(CercleFinance.com) - Roche has announced that the European Commission has approved its Actemra/RoActemra (tocilizumab) for the treatment of giant cell arthritis (GCA), a chronic and potentially life-threatening auto-immune disease.


This decision is based on the results of the Phase III GiACTA study, which showed that a weekly dose results in a statistically significant increase in the proportion of patients achieving sustained remission after a year.

Actemra/RoActemra therefore becomes the first approved therapy in Europe to treat GCA. It was already approved in this indication last May by the American (FDA) and New Zealand (Medsafe) health authorities.


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