Genentech announced today that the FDA has granted breakthrough therapy designation status to Actemra (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The disease is caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.
“The FDA breakthrough therapy designation for GCA underscores our continued commitment to explore Actemra in autoimmune diseases with significant unmet need,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a company news release. “We are looking forward to working with the FDA in the hope of making Actemra available to people with GCA, a condition for which there has been no approved treatment in more than 50 years.”
Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. This is the fourteenth breakthrough therapy designation granted to Genentech since 2013, and the second for Actemra.
In June of this year, Genentech announced the positive outcome of the phase 3 GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a 6-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with GCA. Full data will be presented at an upcoming medical meeting in 2016.