Posted by Michael Wonder on 22 Jul 2017
Roche gains positive CHMP opinion for Actemra / RoActemra in giant cell arteritis
21 July 2017 - The positive opinion is based on the outcome of the phase III GiACTA study.
Roche announced today that the CHMP has adopted a positive opinion recommending approval of Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition.
Based on this positive CHMP recommendation, a final decision regarding the approval of Actemra / RoActemra for the treatment of GCA is expected from the European Commission in the near future. If approved, Actemra / RoActemra would be the first therapy for the treatment of GCA in Europe.
