Genentech announced that the Food and Drug Administration (FDA) has approved Actemra (tocilizumab) subcutaneous injection for the treatment of adults with giant cell arteritis (GCA). This approval marks the first treatment option for GCA in adults. Prior to Actemra, treatment for GCA was limited to high-dose steroids used as an emergency treatment option.
“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, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA approval was based on data from the Phase 3 GiACTA study, a global, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of Actemra (n=251). The primary endpoint was evaluated at 52 weeks.
In the study, Actemra (weekly or bi-weekly), initially combined with a 6-month glucocorticoid regimen, more effectively sustained remission through Week 52 (56% and 53.1%, respectively) than placebo combined with a 26-week steroid taper and a 52-week steroid taper (14% and 17.6%, respectively).
Actemra, an interleukin-6 antagonist, is already indicated to treat moderately-to-severely active rheumatoid arthritis (RA) in patients who have had an inadequate response to ≥1 DMARDs; as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs. It is also indicated to treat active systemic juvenile idiopathic arthritis (SJIA) or active polyarticular juvenile idiopathic arthritis (PJIA) as monotherapy, or in combination with methotrexate. It was granted Priority Review and Breakthrough Therapy Designation by the FDA for GCA.
Actemra is available as 20mg/mL strength vials or 162mg/0.9mL strength prefilled syringes.
For more information call (800) 228-3672 or visit Actemra.com.