EU CHMP recommends approval of Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis- Roche
The EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra/RoActemra (tocilizumab), from Roche, for the treatment of giant cell arteritis. The positive opinion is based on the outcome of the phase III GiACTA study evaluating Actemra / RoActemra in patients with GCA.
The results showed that Actemra / RoActemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56% in the Actemra / RoActemra weekly group and 53.1% in the Actemra / RoActemra bi-weekly group) compared to 26-week and 52-week steroid tapers given alone (14% and 17.6%, respectively).
Comment: The FDA approved tocilizumab for giant cell arteritis in May 2017.
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