Basel, 24 January 2017
FDA grants priority review for Roche’s Actemra/RoActemra (tocilizumab) supplemental biologics license application for giant cell arteritis, a form of vasculitis
Roche recently announced positive results from a Phase III clinical trial in giant cell arteritis (GCA)
There have been no new therapies for GCA in more than 50 years
Breakthrough therapy designation was granted to Actemra/RoActemra for the treatment of GCA by the FDA in 2016
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental biologics license application (sBLA) for Actemra/RoActemra (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted priority review designation for Actemra/RoActemra for the treatment of GCA. The designation is based on the positive outcome of the Phase III GiACTA study evaluating Actemra/RoActemra in people with GCA. Results showed that Actemra/RoActemra, 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.1