The on Monday for the treatment of giant cell arteritis (GCA), based on the findings of a study known as and ending an era in which long-term steroids were the only option for management.
"We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options," said Badrul Chowdhury, MD, PhD, of the FDA's Center for Drug Evaluation and Research, in a statement.
Tocilizumab is an interleukin-6 receptor-α inhibitor indicated for use in moderate to severe rheumatoid arthritis that has not responded to conventional therapy, and also for some subtypes of juvenile idiopathic arthritis.
Giant cell arteritis is the most common type of vasculitis in individuals 50 and older, and is characterized by symptoms such as headache and visual difficulties. Potential consequences include blindness and aortic aneurysms.
GiACTA enrolled 251 patients with GCA that had been confirmed with a temporal artery biopsy or cross-sectional imaging.
After a year of treatment, 56% of those given weekly doses of subcutaneous tocilizumab plus a short course of prednisone were in sustained remission compared with only 14% of those who had received short course prednisone plus subcutaneous placebo (P<0.0001).
In addition, those who received tocilizumab every other week also had significant benefits, with 53.1% being in sustained remission at 1 year.
The treatment also was shown to be steroid-sparing, with median cumulative steroid exposure of 1,862 mg among those receiving tocilizumab compared with 3,817 mg in those who were on prednisone throughout the yearlong study.
When ľֱ conducted a survey of specialists around the country as to what they thought were the most important advances in rheumatology in 2016, readers responded that the success of tocilizumab in GCA was by far the most significant.