FDA Approves Genentech’s Actemra for Giant Cell Arteritis

Source: Genentech

Monday, May 22, 2017 | FDA Approval/Clearance , Genentech


Genentech 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.

“We’re so excited that the FDA approved Actemra for giant cell arteritis. We haven’t had anything but high-dose steroids for this condition, so having a new therapy that’s not a steroid will be tremendous for patients," Anne Fung, MD, Medical Director, Ophthalmology Medical Affairs, at Genentech, said in an interview with Eyewiretoday.com. "Our patients tend to be on the older side and often times have either diabetes or hypertension or osteoporosis, and high-dose steroids really compound these problems, which cause a lot of anxiety for the patient and physician."

The approval is based on the positive outcome of the phase 3 GiACTA study evaluating Actemra in patients with GCA. The results showed that Actemra, initially combined with a 6-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 United States, 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.

About the GiACTA study

GiACTA (NCT01791153) is a phase 3, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the first successful clinical trial conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The primary endpoint was evaluated at 52 weeks.

 

 


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