GCA treatment gets priority review

The FDA has granted priority review designation for tocilizumab (Actemra), an immunosuppressant candidate for treatment of giant cell arteritis (GCA). If approved, it will be the first new treatment for GCA in half a century.

Genentech previously received Breakthrough Therapy Designation status for the drug.

In November 2016, Genentech announced positive outcomes of the phase 3 study showing that patients receiving tocilizumab, initially combined with a 6-month glucocorticoid regimen, were significantly likely to achieve sustained remission through 1 year, compared to a 6- or 12-month steroid-only regimen in patients with GCA.

Tocilizumab is a monoclonal antibody against the receptor for interleukin-6 (IL-6), an inflammatory cytokine involved in the pathogenesis of many diseases. Actemra is already approved for adults with moderate to severe active rheumatoid arthritis and both polyarticular and systemic juvenile idiopathic arthritis.