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.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins