OCT 05, 2016
The FDA has granted Breakthrough Therapy Designation status to tocilizumab for the treatment of giant cell arteritis (GCA). If approved, it will be the first new treatment for this condition in more than 50 years.
Tocilizumab (Actemra) is the first humanized monoclonal antibody against the interleukin-6 receptor (IL-6R), a cytokine that plays an important role in immune response. It is approved for adults with moderate to severe active rheumatoid arthritis who have used one or more disease-modifying anti-rheumatic drugs, such as methotrexate, that did not provide enough relief.
"The results of Genentech's trial are encouraging for GCA patients and the physicians who treat them," said Philip R. Rizzuto, MD, FACS, clinical associate professor of ophthalmic surgery at Brown University, Warren Alpert Medical School. "Long-term, high-dose steroid use can be problematic for many people. Having an alternative treatment would be welcome news."
Breakthrough designation is intended to expedite the development and review of drug candidates with early evidence of substantial treatment advantages over existing options for patients with serious or life-threatening diseases. This is the second such designation for Actemra.
In June, Genentech announced positive outcomes of the phase 3 study showing that tocilizumab, initially combined with a 6-month glucocorticoid regimen, more effectively sustained remission through 1 year compared to a 6- or 12-month steroid-only regimen in patients with GCA.