FDA Grants Priority Review for Genentech’s Actemra® sBLA for Giant Cell Arteritis, a Form of Vasculi

Genentech, a member of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra^® (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted Priority Review Designation for Actemra for the treatment of GCA. The designation is based on the positive outcome of the Phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.

"This positive outcome in GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are pleased by the FDA’s decision to classify their review of the sBLA as priority. We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible."

Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.

In October 2016, Genentech announced receiving Breakthrough Therapy Designation for the treatment of GCA with Actemra. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of substantial clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.