FDA Approves First Drug to Treat Giant Cell Arteritis
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved Roche’s Actemra (tocilizumab), the first treatment for adult patients with giant cell arteritis (GCA), a rare autoimmune condition. Also known as temporal arteritis, GCA can cause severe headaches, jaw pain and visual symptoms that, if left untreated, can lead to blindness, aortic aneurysm or stroke. The approval is based on the positive outcome of a Phase III study that showed Actemra, combined with a six-month steroid (glucocorticoid)regimen, more effectively sustained remission of GCA than a placebo.
This is the sixth FDA approval of Actemra since the medicine was launched in 2010. It is also being investigated in a Phase III study for patients with systemic sclerosis, or scleroderma, and was designated a breakthrough therapy for this indication in June 2015.
References
- FDA Approves Genentech’s Actemra® for Giant Cell Arteritis. Vasculitis Foundation, May 22, 2017. Accessed at www.vasculitisfoundation.org/fda-approves-genentechs-actemra-for-giant-cell-arteritis.
