FDA approves Actemra (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis.- Genentech/Roche

Genentech, a member of the Roche Group , announced that the FDA has approved Actemra (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.

The approval is based on the positive outcome of the Phase III GiACTA study evaluating Actemra in patients with GCA. The results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks (56 percent in the Actemra weekly group and 53.1 percent in the Actemra bi-weekly group) compared to placebo combined with a 26-week steroid taper (14 percent) and placebo combined with a 52-week steroid taper (17.6 percent).

GCA, also known as temporal arteritis (TA), affects an estimated 228,000 people over the age of 50 in the U.S., and the disease is two to three times more likely to affect women than men. GCA is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke. Treatment to date for people with GCA has been limited to high-dose steroids that play a role as an effective ‘emergency’ treatment option to prevent damage such as vision loss. Due to the variability of symptoms, complexity of the disease and disease complications, people with GCA are often seen by several physicians including rheumatologists, ophthalmologists and neurologists.