Earlier today, Genentech announced it has received U.S. FDA approval for Actemra® (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA).
According to Genentech, Actemra is the first therapy approved by the FDA for the treatment of adult GCA, and is the sixth FDA approval for Actemra since the medicine was launched in 2010.
The approval is reportedly based on the positive outcome of the Phase III GiACTA study evaluating Actemra in patients with GCA. The results reportedly showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through 52 weeks compared to placebo combined with a 26-week steroid taper and placebo combined with a 52-week steroid taper.
GCA, also known as temporal arteritis (TA), reportedly affects an estimated 228,000 people over the age of 50 in the U.S., and is two to three times more likely to affect women than men. The condition reportedly can cause visual issues, severe headaches and jaw pain, and if left untreated can lead to blindness.
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