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FDA Grants Priority Review for Actemra for Treatment of Giant Cell Arteritis
The FDA has accepted a supplemental biologics license application for tocilizumab (Actemra/RoActemra, Roche) for the treatment of patients with giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The agency also granted priority review status to tocilizumab for GCA. This designation was based on positive results from the phase 3 GiACTA study, in which tocilizumab, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared with a six- or 12-month steroid-taper regimen given alone in patients with GCA.
Tocilizumab is the only approved anti–interleukin (IL)-6 receptor biologic, available in both intravenous and subcutaneous formulations, for the treatment of adults with moderately or severely active rheumatoid arthritis. Tocilizumab can be used alone or with methotrexate in adults who are intolerant of or have failed to respond to other antirheumatic medications.
A priority review designation is granted to medications that the FDA has determined to have the potential to provide significant improvements in the safety and efficacy of the treatment of a serious disease.
In October 2016, Roche announced a breakthrough therapy designation for tocilizumab for the treatment of patients with GCA. This designation is intended to expedite the development and review of medications with early evidence of substantial clinical benefit in serious diseases and to help ensure that patients receive access to medications as soon as possible.
The GiACTA trial was a global, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of tocilizumab in 251 patients with GCA. The study’s primary and key secondary endpoints were evaluated at 52 weeks.
Tocilizumab is also being investigated in a phase 3, global, randomized, double-blind, placebo-controlled study in patients with systemic sclerosis (SSc). Tocilizumab was granted a breakthrough therapy designation for SSc by the FDA in June 2015.
Source: Roche; January 24, 2017.