Wednesday, February 1, 2017
Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted Priority Review designation for Actemra for the treatment of giant cell arteritis (GCA). The designation is based on the positive outcome of the phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.